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Understanding DSCSA and A Collaboration to Continuing Ed MPhA Annual Awards |

How it Impacts You Enrich the Future Management of Type 2 Individual professional
There is no time to waste Diabetes: Review of Drug excellence recognized
in getting prepared for the Leader of Maryland Therapy and the Role of during the MPhA Annual
March. 2016 enforcement of Pharmacy the Pharmacist Convention

DSCSA

PRSRT STD
U.S. POSTAGE
HARRISBURG PA
PERMIT NO. 533

FUTURE

LEADERS

OF PHARMACY

Diabetes Drug Therapy
Management

R.J. HEDGES

& ASSOCIATES

Are you able to easily complete
CVS/Caremark, Catamaran and other PBM
Attestations and Credentialing requirements?

GET YOUR RESULTS AT

PHARMACY CREDENTIALING ASSESSMENT

vesno @ FWA

Are you conducting FWA Prevention training annually?
Do you have an “Anti-Kickback” Policy & Procedure (P&P)?
Do you have your entire staff completing Conflict of
Interest forms annually?
Are you running OIG-GSA-SAM Exclusion Verifications each month on:
Employees, Owners and Contractors
Business Associates
All vendors whose products are billed through Medicare

HIPAA

YES
Do you have a HIPAA P&P manual/program in place?
Has your Notice of Privacy Practice been updated since
July 1, 2013?
Do you maintain a breach assessment when the patient
receives another patient's medication?

YES PATIENT SAFETY

Do you have a Quality Assurance Program?
Are you enrolled in a Patient Safety Organization?

We’re here to keep you

SALES@RJHEDGES.COM

724-357-8380

Ares

Do you

Adhere

vesNo @ PHARMACY OPERATIONS

aff members trained on CMS 10147
Ice if a “569 error” occurs?

—

have Policies at
rarmacy Medicare Part D credentialing
requirements?

e you keeping annual records of all trainings
(HIPAA & FWA with 10 years of retention)?

Do you review your EQuiPP scores monthly?

Do you have a Medication Adherence Program?
have P&P’s for:

Jsual and Customary

Patient Counseling Practices

Vlis-fill Procedures

Medication Recall Procedures

Medication Expiration Procedures
aeneric/Brand Price Disclosures

Demographics and Allergy Capture

Partial Refills

Return to Stock

and in compliance!

WWW.RJHEDGES.COM

d Procedures (P&P) to meet

6
COVER STORY

On November 7, 2015, twenty-five student
pharmacists and eighteen new practitioners

and experienced pharmacists from across : COALS SUCCESS
the state attended a successful collaborative ate N SELF-ASSESSMENT

leadership workshop hosted by the ; VISION: VALU MEETINGS
Baraaccieten dership PCREAUICatOn \ MEMBERS, CHAIRMAN,» EFFECTIVENESS, | PAWAICHMMMON)) ISSUE NEGOTIATION
Institute (PLEI) and sponsored by the Maryland
Pharmacists Association (MPhA) Foundation.
PLEI Board Members Gary Keil, PAD and
Michael Negrete, PharmD led the all-day
workshop while MPhA members Monica
Healy and Tim Rocafort provided

facilitation assistance.

14 a

7 | Save the Dates

9 | Member Mentions

11 | Understanding DSCSA and
How it Impacts You

13 | MPhA Annual Awards

21 | Welcome New Members

Management of Type 2 Diabetes:
Review of Drug Therapy and the

mL:

Role of the Pharmacist

.
ADVERTISERS INDEX el CE Quiz

21 Corporate Sponsors

2 RJ. Hedges & Associates
5 Buy-Sell-A-Pharmacy
8 Cardinal Health
10 HD Smith
12 Bowl of Hygeia Award
22 Pharmacists Mutual
24 University of Maryland

MARYLANDPHARMACIST.ORG 3

President’s Pad

“1 believe that the state of MPhA is
strong and growing thanks to

your ongoing engagement and
support. As a team, let’s continue
to carry out MPhA’s mission:
Strengthen the profession of
pharmacy, advocate for all
Maryland pharmacists, and promote
excellence in pharmacy practice.”

Dear Fellow MPhA Members,

Happy New Year. May 2016 bring you many blessings, especially health and
happiness. Also, happy belated National Pharmacist Day which was on January i2.
Did you know that was a day? I have been a pharmacist for over ten years and I
did not know. My wife, Tanya, pointed that out to me. I always like to find reasons
to celebrate our profession, so mark it on your calendar for next year!

I hope that you were able to attend MPhA’s Open House in February to celebrate
MPhA‘s new headquarters in Columbia. If not, please invite your pharmacy friends
and colleagues to visit, especially if they are coming from across the country to
attend the APhA Annual Meeting in Baltimore on March 4-7. There is plenty of
history in the new space for everyone to appreciate.

Also, big congratulations to Executive Director Aliyah Horton, CAE. This is her
one year anniversary since joining in January 2015. Aliyah has facilitated MPhA’s
move to the new headquarters and worked with members and staff to create a
welcoming space. She has worked to provide more opportunities for member
engagement and has transformed our new home into a venue that enhances
the collaboration and professional development of the Maryland pharmacy
community.

In addition, she has actively worked on behalf of MPhA to maintain long-term
partnerships and build new networks of support in Annapolis as well as with the
Department of Health and Mental Hygiene, the Board of Pharmacy, the Maryland
Pharmacy Coalition and other affiliated communities. These relationships helped
MPhA to have a more powerful voice in addressing challenges faced by different
practice settings over the course of 2015 and will create new opportunities for
2016. Finally, she has worked with the MPhA leaders to create a strategic plan to
guide our work over the next few years with a focus on governance, membership
value, recruitment and retention.

In regards to MPhA’s Strategic Plan, one of the three goals is to align MPhA
governance to facilitate organizational growth and pharmacy community
engagement. Thank you to all the members of the Board Compositions Task
Force, led by Past MPhA Honorary President Dr. Lynette Bradley-Baker, for multiple
meetings and great efforts to research board compositions of professional
organizations and provide recommendations on changes to MPhA’s Board of
Trustees that will advance MPhA’s long-term strategic objectives. One deliverable

Continued on next page

4 MARYLAND PHARMACIST | WINTER 2015

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Est, 98? MARYLAND PHARMACISTS ASSOCIATION

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MANAGING EDITOR
Kelly Fisher

MPhA OFFICERS 2015-2016

Dixie Leikach, RPh, MBA, FACA,
Chairman

Hoai-An Truong, PharmD, MPH,
President

Kristen Fink, PharmD, BCPS, CDE, Vice
President ;

Matthew Shimoda, PharmD, Treasurer

Thomas Menighan, BS Pharm, MBA, ScD,
FAPhA, Honorary President

HOUSE OFFICERS

W. Chris Charles, PharmD, BCPS, AE-C,
Speaker

Ashley Moody, PharmD, BCACP, AE-C,
Vice Speaker

MPHKA TRUSTEES

Nicole Culhane, PharmD, BCPS, FCCP.
2016

Mark Lapouraille, RPh, 2016

Cherokee Layson-Wolf, PharmD, CGP,
BCACP, FAPhA, 2017

G. Lawrence Hogue, BSPharm, PD, 2017

Wayne VanWie, RPh, 2018

Chai Wang, PharmD, BCPS, AE-C, 2018

Shannon Riggins, ASP Student President

University of Maryland Eastern Shore

School of Pharmacy

EX-OFFICIO TRUSTEES
Rondall Allen, PharmD, Dean
University of Maryland Eastern Shore
School of Pharmacy
Natalie Eddington, PhD, Dean
University of Maryland School of
Pharmacy
Anne Lin, PharmD, Dean
Notre Dame of Maryland University
School of Pharmacy
David Jones, RPh, FASCP, MD-ASCP
Representative
Celia Proctor, PharmD, MBA, MSHP
Representative
Hanna Fenta, ASP Student President
Notre Dame of Maryland University
School of Pharmacy
Elissa Lechtenstein, ASP Student
President
University of Maryland School of
Pharmacy

PEER REVIEWERS

W. Chris Charles, PharmD, BCPS, AE-C

Caitlin Corker-Relph, MA, PharmD
Candidate 2017

G. Lawrence Hogue, BSPharm, PD

Hanna Salehi, PharmD, MLS

STAFF

Aliyah N. Horton, CAE, Executive
Director

Kelly Fisher, Marketing Coordinator

Shawn Collins, Membership Services
Coordinator

We welcome your feedback and

ideas for future articles for Maryland
Pharmacist. Send your suggestions to
Kelly Fisher:

Maryland Pharmacists Association, 9115
Guilford Road, Suite 200, Columbia, MD
21046, call 443.583.8000, or email kelly.
fisher@mdpha.com.

Special thanks to Graphtech, Advertising —

Sales and Design , :

already utilized was for the 2016
election. A guidance document
was provided to the MPhA staff and
Nominations Committee to assist in
ensuring a formal process for MPhA
elections and addressing diversity
in election candidates. Stay tuned
for specific recommendations,
discussions, and vote on the

Board compositions at the Annual
Convention.

Membership engagement and
regional outreach have continued
to be a focus of my, or better yet,
our presidency. Special thanks

to several MPhA members and
partners throughout the State for
planning and/or hosting MPhA focus
groups on membership value: Matt
Balish, Tom Sisca, Darci Eubank,
Brian Hose, Rosemary Botchway,
the Eastern Shore Pharmaceutical
Society, and the Primary Care
Coalition of Montgomery County.
The results and feedback will help

with membership programs and
recruitment efforts. In addition,
please continue to ask your
pharmacist colleagues who are
not MPhA members to ‘Ask Me

2 about MPhA’ in an effort to
recruit members. Together, we can
advocate better and stronger for
our beloved profession. As always,
if you have ideas or suggestions for
programs or events, please reach
out to me directly at htruong@
abcforyourhealth.org.

For the upcoming spring, |! am
excited to share the launch of the
MPhA Federal Pharmacists Network.
Thank you to the co-founders LCDR
Mathilda Fienkeng, CAPT Mary
Kremzner, and CAPT (retired) James
Bresette for all their leadership. Stay
tuned for more information. Also,
thank you to the New Practitioner
Network and co-chairs Lauren
Lakdawala and Sam Houmes for
assisting with the bi-monthly

1-(877)-360-0095

www.buy-sellapharmacy.com

A 15-year track record of successfully completing
more than 400 independent pharmacy sales.

membership program on April 21.
This program will target the needs
of recent and upcoming graduates.
Check our website for more
information as the date draws closer.

I believe that the state of MPhA is
strong and growing thanks to your
ongoing engagement and support.
As a team, let's continue to carry
out MPhA‘s mission: Strengthen the
profession of pharmacy, advocate
for all Maryland pharmacists, and
promote excellence in pharmacy
practice.” @

Sincerely,

fees Jae Muang -

Hoai-An Truong, PharmD, MPH
President

Tel: 1-(732)-563-0295

Completely Confidential!

The road from the contemplation of a sale to the closing of a deal
is filled with obstacles, road blocks and speed bumps.
Let us help you navigate them successfully.

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This is what we do every day, all day. It’s a full time job. Don't
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MARYLANDPHARMACIST.ORG 5

By: James L. Bresette, PharmD

Shannon Riggins, PharmD Candidate 2017, University
of Maryland Eastern Shore School of Pharmacy

Cover Story

A Collaboration to
Enrich the Future Leaders of

Maryland Pharmacy

n November 7, 2015, twenty-five

student pharmacists and eighteen

new practitioners and experienced
pharmacists from across the state attended a
successful collaborative leadership workshop
hosted by the Pharmacists Leadership and
Education Institute (PLEI) and sponsored
by the Maryland Pharmacists Association
(MPhA) Foundation. PLEI Board Members
Gary Keil, PhD and Michael Negrete, PharmD
led the all-day workshop while MPhA
members Monica Healy and Tim Rocafort
provided facilitation assistance.

Due to the work of Dr. Jim Bresette, Phi
Lambda Sigma (PLS) funded a grant to
support student pharmacists from the PLS
chapters in each of the Maryland schools of
pharmacy to participate in this workshop.
This was the first time that all Maryland PLS
chapters collaborated together. “Consistent
with PLS mission and goals, this initiative
was perfectly aligned to actively grow and
prepare the next generation of Maryland
pharmacists for leadership positions in their
future work places and within the Maryland
Pharmacist Association,” said proudly by Dr.
Jim Bresette.

Ha Phan, a third-year student at the
University of Maryland School of Pharmacy,
appreciated these efforts, “I enjoyed being
able to interact with my fellow colleagues
irom different pharmacy schools who are
also leaders in their schools. It was nice to
see the overlap in core values and listen to
what other students are passionate about."

The goal of the PLEI workshop was to
discuss what it takes to be an effective
leader, illustrate how to identify peoples’
strengths and align them with appropriate
tasks, and examine how values can be used
to allocate limited time and resources to

6 MARYLAND PHARMACIST | WINTER 2016

New practitioners who participated in the PLEI workshop

maximize meaning
and purpose.
Participants were
asked not only

to look at their
strengths, but also
their weaknesses

in order to assess
What areas could

be causing them

to falter as leaders.
After participating
in several activities
aimed at self-
analysis, participants
were asked to share
their conclusions
through “pair
sharing” and discuss
the variances and
Similarities that came
up as a group.

‘LTremember a
particular moment
when the PLEI
facilitator asked
everyone to raise
their hand if
conflict resolution
DID NOT bother
them. After seeing
an overwhelming
number of leaders
raise their hands,

I was shocked
because | had
never thought the
topic of leadership
could be made into
a constructively
positive experience.
It then gave me a
goal to work towards
as a leader so that I,

too, could feel that
way, said Geoffrey
Saunders, a second-
year student at

the University of
Maryland Eastern
Shore School Of
Pharmacy.

During lunch, PLS
chapter leaders
from each of the
schools of pharmacy
sat together to talk
about their chapters
experiences and
goals for the
upcoming year

and to collect input
about how to deal
with challenges they
might face. “This
was an amazing

opportunity to learn from our fellow
PLS members that we would not
ordinarily have the opportunity

to work with,” said Brittany La-
Viola, a fourth-year student at the
Notre Dame of Maryland School of
Pharmacy.

In one of the final activities of the
day, each participant came up
with a few goals for themselves
and were asked to form an
“accountabilibuddy” partnership
to help achieve these goals.

Ryan Button of the University of
Maryland School of Pharmacy
expressed his viewpoint, “It’s about
building interpersonal skills and
interprofessional relationships.

I look at it as a chance to reach
out to someone that understands
the ebbs and flows, the stresses
and satisfactions, which we all
experience. It’s saying, ‘I'm taking
accountability for you taking care of
yourself so that we can accomplish
something special together.’ It's a
unique way to establish trust with
someone.”

After a long day of reflection,
sharing, and goal-setting, Rite Aid
Corporation generously sponsored
a networking dinner where

new practitioners and student
pharmacists continued to interact
with one another and share their
perspectives on what had transpired
for them throughout the day. It
was clear that all participants found
this workshop to be a valuable

Student pharmacists who participated in the PLE! workshop

experience in developing their
leadership skills.

“The PLEI workshop is by far the
most ambitious project that the
MPhA Foundation has sponsored.
The success of the workshop is
vital to the future of the MPhA
Foundation and its fundraising
efforts as it illustrates what can be
accomplished when resources are
available to fund such endeavors.
Financial support of the MPhA
Foundation is necessary in order to
continue its mission of supporting
student pharmacists, recognizing
practice innovation and in this
instance, enhancing philanthropy

Save the Dates

that supports leadership,” said MPhA
Foundation President Paul Holly.

On behalf of the students from
Beta Lambda, Delta Beta, and Delta
Nu chapters of PLS in Maryland,

we owe a collective thank you to
PLS National, MPhA Foundation,
MPhA, Rite Aid Corporation, and
PLEI for the incredible and ennching
experience that this workshop

has given Maryland student
pharmacists and new practitioners
as we move forward through the
profession as the future leaders of
pharmacy. To donate to the MPhA
Foundation, please visit www.
marylandpharmacist.org. @

5 17 27
Maryland Pharmacy March Board of Script Your Future
Night at APhA Trustees Meeting April 27,
Annual Meeting & March 17, MPhA HQ
Exposition MPhA HQ
March 5,
Baltimore, MD

Visit www.marylandpharmacist.org to register online or for more information.

May Board of
Trustees Meeting
May 12,
MPhA HQ

12 10-12

134th Annual
Convention
June 10-12, Ocean
City, MD

MARYLANDPHARMACIST.ORG 7

W a leader.
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MEMBER MENTIONS

MPhA Past
President Dixie
Leikach, RPh,
MBA has formed
a non-profit
organization,
Pharmacy Ethics,
Education and
Resources
(PEER), and is
the President and CEO. The mission
of PEER is to educate healthcare
professionals on ethics to improve
patient safety. The initial focus

of PEER is to develop a series of
continuing education programs
focusing on the role of ethics in

all areas of pharmacy and how
ethics impacts patient safety. An
ethics certificate program is also in
development for those who would
like to establish themselves as
leaders in pharmacy ethics. If you
are interested in more information
about PEER, please visit www.

PeerRx.org.

MPhA President
Hoai-An
Truong,
PharmD, MPH
has returned to
the University of
Maryland Eastern
Shore School

of Pharmacy
and Health
Professions as an Associate
Professor in January 2016. Dr.
Truong is a public health pharmacist,
educator, and leader for over ten
years. He has provided patient-
centered care in an interprofessional
collaborative model, part of

the Primary Care Coalition of
Montgomery County, focusing on
medication therapy management

to optimize medication use and

improve healthcare access, quality,
and outcomes for underserved
populations. Hoai-An has served
as coordinator and preceptor for
pharmacy and physician assistant
students on a health mission trip
to Haiti. He has also mentored
public health students on a needs
assessment trip to Vietnam and
recently became a co-founder of
International Community Initiative.

Seeeeeeseneeeeeeeeeeseeeteeeeeeeeeseeeeeees

MPhA Trustee
Cherokee-
Layson Wolf,
PharmD, BCACP,
FAPhA has been
recognized with
the American
Pharmacist
Association-
Academy of
Student Pharmacists’ (APhA-ASP)
Outstanding Chapter Advisor Award.
This award recognizes advisors

of APhA-ASP chapters who have
promoted with distinction the
welfare of student pharmacists
through various professional
activities. Cherokee is an associate
professor in the Department of
Pharmacy Practice and Science and
associate dean of student affairs at
the University of Maryland School of
Pharmacy.

eeceeseeeseeseoseeeeseeeseeeeseseseeeeeeeeeeae

Bethany
DiPaula,
PharmD, BCPP
has been named
a specialist
member on
the Board of
Pharmacy
Specialties’
Council

on Psychiatric Pharmacy. The
psychiatric pharmacy specialist is

often responsible for optimizing
drug treatment and patient care

by conducting such activities

as monitoring patient response,
patient assessment, recognizing
drug-induced problems, and
recommending appropriate
treatment plans. Bethany is

an associate professor in the
Department of Pharmacy Practice
and Science at the University of
Maryland School of Pharmacy which
is where she also received her
Doctor of Pharmacy and completed
her psychiatric pharmacy specialty
residency.

Seeeeeeeseseseeeeseeoeseoseseseeseeeesesees

In Memoriam

Itis with
great
sadness we
share that
long-time
member
Richard
“Dicks
Baylis,
PDeCEP.
FASCP
passed
away on November 22, 2015.

Dick was the MPhA President in
2003 and the 2005 recipient of the
Seidman Distinguished Achievement
Award. He graduated from Albany
College of Pharmacy in New York
and worked in community, hospital,
and long-term care pharmacy. Dick
was also very active in the Maryland
Chapter of American Society of
Consultant Pharmacist (MD-ASCP)
and served as president. After he
retired, he became the Executive
Director of the Georgia-ASCP
Chapter. MPhA and MD-ASCP held

a Morning of Remembrance on
December 12 at MPhA Headquarters.
o

MARYLANDPHARMACIST.ORG 9

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Helping You Care For Your Community

While DSCSA went into effect
over a year ago, its enforcement
was delayed until March 1, 2016.
MPhA knows that there is no
time to waste in getting a
solution in place. We have
partnered with InfiniTrak, a track
and trace software designed for
independent pharmacists, to
provide members with a deep
discount on a timesaving
solution to your DSCSA
compliance needs. InfiniTrak
helps you become compliant
with the three key requirements
of DSCSA and ensures that you
remain compliant as the
regulations continue to roll out.
Here’s what you need to know!

WHAT IS the Drug
Supply Chain Security
Act?

Created to ensure that our
national drug supply is safe from
counterfeit drugs, and that our
pharmaceutical supply is safe and
effective, DSCSA builds a
nationwide electronic database
that will track the ownership
history of prescription drugs.

New Member Benefit!

Understanding DSCSA
and How it Impacts YOU!

Drug Supply Chain Security Act (DSCSA) Readiness

Verification

Do you have a business
process in place to verify that
your trading partners are
properly licensed under
federal or state law? Before
you purchase a product from a
wholesaler, you need to verify
that the wholesaler is licensed
to do business in your state.
You also have to be sure your
pharmacy is properly licensed
- trading partners will be
verifying you, as well.

InfiniTrak includes a series
of built-in work flows to
help you analyze and
investigate any possible
tainted product.

Transaction Data
Management

Do you hold transaction data
for 6 years and, if need be, have
a system to retrieve the
information for submission to
federal or state authorities
within 48 hours? If you are
asked to research a product in
response to the FDA regarding a
potential suspect product, do
you have a system to keep the
information for an additional 6
years?

Visit: www.infinitrak.us for more information

InfiniTrak manages the
verification process for
you and reminds you
when your own license is
coming up for renewal.

Suspect Product
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Do you have a process in place to
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employees about how to be on
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InfiniTrak holds your
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MARYLANDPHARMACIST.ORG 11

2015 Recipients of the “Bowl of Hygeia” Award

St, é je = a.
Dan McConaghy Tom Van Hassel Nicki Hilliard Robert Shmaeff Sherman Gershman Kevin Musto Fritz Hayes Ron Stephens
Alabama Arizona Arkansas California Connecticut Delaware Florida Georgia

Sd ood
eae
« /
’ Ne P,
ae. bee
Kerri Okamura Steven Bandy Jane Krause Richard Hartig Robert Nyquist Larry Stovall Lloyd Duplantis Kenneth McCall

Hawaii Illinois Indiana lowa Kansas Kentucky Louisiana Maine

Butch Henderson Paul Jeffrey Derek Quinn Jenny Houglum Robert Wilbanks Richard Logan
Maryland Massachusetts Michigan Minnesota Mississippi Missouri

p< sf oY ha
Gayle Hudgins Heather Mooney Richard Crowe
Montana Nevada New Hampshire

Edward McGinley Amy Bachyrycz Benjamin Gruda
New Jersey New Mexico New York

David Moody Kevin Oberlander Danny Bentley Gordon Richards, Jr. Ann Zweber Thomas Mattei Deborah Newell Sharm Steadman
North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina

Renee Sutton Mac Wilhoit Jim Cousineau Marvin Orrock John Beckner Gregory Hovander
South Dakota Tennessee Texas Utah Virginia Washington

Terri Smith Moore David Flynn Brian Jensen Randy Harrop
Washington DC West Virginia Wisconsin Wyoming

The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation
FOUNDATION for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these
dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks
for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the
State pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are
encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bow! of
Hygeia is on display in the APhA Awards Gallery located in Washington, DC.

Boehringer Ingelheim is proud to be the Premier Supporter of the Bowl of Hygeia program.

2016 Maryland Pharmacists
Association Awards
Recognizing Pharmacy Excellence

Each year, MPhA recognizes individual professional excellence during MPhA’s Annual Convention. To nominate a
deserving pharmacist for one of the awards described below, please visit us online to complete the nomination form
at www.marylandpharmacist.org. You must include a brief statement and the nominee's current resume or curriculum
vitae. Nominations are reviewed and selections are made by the Past Presidents Council. For consideration,
nomination forms must be received by Friday, March 25, 2016.

Bowl of Hygeia Award

sponsored by the American Pharmacists Association
Foundation and National Alliance of State Pharmacy
Associations

Established in 1958, the Bowl of Hygeia Award recognizes
pharmacists who possess outstanding records of civic
leadership in their communities and encourages pharmacists
to take active roles in their communities. In addition to service
through their local, state, and national pharmacy associations,
award recipients devote their time, talent, and resources to

a wide variety of causes and community service. Any MPhA
pharmacist member who has not already received the Bowl of
Hygeia Award is eligible for nomination.

The Bowl of Hygeia is the most widely recognized international
symbol for the pharmacy profession and is considered one of
the profession's most prestigious awards. The Bowl of Hygeia
has been associated with the pharmacy profession since 1796,
when the symbol was used on a coin minted for the Parisian
Society of Pharmacy. The bowl represents a medicinal potion
and the snake represents healing.

Maryland Pharmacists Association Seidman
Distinguished Achievement Award

Created by Henry Seidman, this award honors a Maryland
pharmacist who has performed outstanding service over a
number of years and whose service has resulted in a major
impact on the pharmacy profession. Any MPhA pharmacist
member who meets the criteria for this award is eligible for
nomination.

Excellence in Innovation Award

sponsored by Upsher-Smith Laboratories, Inc.
Established in 1993, this award (formerly known as the
Innovative Pharmacy Practice Award) aims to recognize
forward-thinking pharmacists who have expanded their
practices into new areas. Any practicing MPhA pharmacist
member within the geographic area who has demonstrated
innovative pharmacy practice resulting in improved patient
care is eligible for nomination.

Distinguished Young Pharmacist Award
sponsored by Pharmacists Mutual Companies
This award is presented each year to a pharmacist who has

graduated within the past ten years and has made a significant
contribution to the profession through service to a local, state,
or national pharmacy organization. Any MPhA pharmacist
member who has graduated from a school of pharmacy within
the last ten years is eligible for nomination.

Maryland Pharmacists Association Mentor Award
This award recognizes individuals who encourage pharmacists,
technicians, and/or student pharmacists in the pursuit of
excellence in education, pharmacy practice, service, and/

or advocacy. Any MPhA pharmacist member who meets the
criteria for the award is eligible for nomination.

Cardinal Health Generation Rx Champions Award
sponsored by Cardinal Health Foundation

This award honors a pharmacist who has demonstrated
outstanding commitment to raising awareness of the dangers
of prescription drug abuse among the general public and the
pharmacy community. Any MPhA pharmacist member who
meets the criteria for the award is eligible for nomination.

Maryland Pharmacists Association

Honorary President

An honorary position on the Board of Trustees is given to a
person, not necessarily a pharmacist, who has worked for
MPhA or Maryland Pharmacy over a long period of time. Any
long standing contributor to the profession or the Association
is eligible for nomination. @

This year’s Annual Convention will be
on June 10-12 in Ocean City, MD at the
Clarion Resort Fontainebleau Hotel.
Online registration will open in the

spring. Be sure to follow our Annual
Convention hashtag, #MPhAAnnual,
for news and updates!

MARYLANDPHARMACIST.ORG 13

Continuing Ed

Zemen Habtemariam, PharmD Candidate 2016
Nina M. Bemben, PharmD, BCPS
Mary Lynn McPherson, PharmD, MA, BCPS, CDE

University of Maryland School of Pharmacy

In the United States, diabetes is a major chronic disease. An estimated 29 million Americans have diabetes and of
these, nearly 28 million Americans have type 2 diabetes. Diabetes remains the seventh leading cause of death in this
country, and people with diabetes are 1.7 times more likely to die from cardiovascular disease than people without
diabetes.'* Other potential complications of type 2 diabetes include cerebrovascular and peripheral vascular disease,
retinopathy, nephropathy, and neuropathy.’ In addition, hypoglycemic events associated with the disease account for
approximately 282,000 emergency room visits every year.!

While the complications of diabetes certainly increase morbidity and decrease patient quality of life, diabetes also has
an effect on patient mortality. Zhuo and colleagues conducted a study that helped measure the impact of diabetes
on patient life expectancy.* They found among patients at age 40 years, those with diabetes lose an average 6.7
survival-adjusted life years compared to patients without diabetes.’ Besides the direct effect on patient lives, diabetes
also results in costs to the healthcare system and society at large. According to the Centers for Disease Control and
Prevention (CDC), in 2012 direct medical costs attributable to diabetes were $176 billion and indirect costs, such as
disability and reduced life expectancy, amounted to $69 billion.’

14 MARYLAND PHARMACIST | WINTER 2016

Diagnosis of Diabetes
Mellitus

The American Diabetes Association
(ADA) has developed four criteria for
the diagnosis of diabetes mellitus
and has established a diagnostic
category referred to as prediabetes
for patients at increased risk of
developing diabetes.° Testing for
asymptomatic people should

be considered for children and
adults who are overweight or

obese and who have one or more
risk factors for diabetes. Testing
should begin at the age of 45 in all
patients regardless of weight. When
diagnosing diabetes, in the absence
of a clear clinical diagnosis (e.g,.,
hyperglycemic crisis), a second test
is required to confirm diagnosis

of diabetes mellitus. Criteria for
diagnosing prediabetes and diabetes
are as follows in the chart to the right.°

Goals of Care

The ADA has made recommenda-
tions for glycemic control, as well as
recommendations for blood pres-
sure and cholesterol management.
Glycemic targets are as follows,
although targets may be customized
for individual patients:®

e Alc < 70 %

e Preprandial capillary plasma glu-
cose 80-130 mg/dl

e Peak postprandial (1-2 hours post
beginning of meal) capillary plas-
ma glucose < 180 mg/dl

As shown above, the ADA recom-

mends achieving a glycosylated
hemoglobin (HbA1c) of <7.0%.°

2 hour post-prandial

Random plasma glucose
with classic symptoms of
hyperglycemia

Blood glucose levels consistent
with this therapeutic goal are

<130 mg/dL for fasting glucose

and <180 mg/dL for a two-hour
post-prandial.* The ADA does
recommend individualizing
therapeutic goals depending ona
patient's remaining life expectancy,
duration of disease, presence of
complications of diabetes, as well as
other comorbidities.*° For example,
for a relatively young patient with
newly diagnosed type 2 diabetes,
no comorbidities or complications
such as retinopathy or nephropathy,
and a presumably long life-
expectancy, more stringent control
of blood glucose with a target
HbAtic of 6.0-6.5% is appropriate.
Conversely, in an elderly patient
with long-standing diabetes already
suffering from complications

such as retinopathy and multiple
comorbidities, the benefits of
stringent blood glucose control
(decreased risk of microvascular
complications) are not likely to
outweigh the risks of hypoglycemia
and adverse effects and a less
stringent HbAtc goal of 7.5-8.0%
may be reasonable.*

CRITERIA — | _ | PREDIABETES | DIABETES MELLITUS
Fasting plasma glucose 100-125 mg/dl > 126 mg/dl
(defined as no caloric
intake for at least 8 hours)
140-199 mg/dl > 200 mg/dl
(following WHO guidelines
for testing)

ee ae

The ADA recommends people with
diabetes and hypertension should
be treated to a systolic blood pres-
sure goal of <140 mmHg, although
a goal of <130 mmHg may be more
appropriate for selected patient
populations.’ Diastolic blood pres-
sure should be <90 mmHg, or <80
mmHg for selected patients.’ For
people with diabetes under the age
of 40 and no cardiovascular risk

_ factors, no pharmacologic ther-

apy is recommended to manage
lipids. Patients over the age of 40
and those with cardiovascular risk
factors should receive statin therapy
(moderate or high intensity)’

Role of the Pharmacist

As medication experts, pharmacists
are well trained to evaluate and
improve drug regimens designed
to maximize clinical, economic
and humanistic outcomes from
diabetes mellitus. As discussed later
in this article, pharmacists may
also provide patient education,
both through patient counseling
and Diabetes Self-Management
Education (DSME) courses.

| ee é ee . we
| Key Words ©

| "* diabetes |

| * diabetes self-management

| education

| « type 2 diabetes ie sai
"antidiabetic agents

MARYLANDPHARMACIST.ORG 15

To provide the best care to our
patients, pharmacists should

be familiar with the appropriate
treatment of diabetes and treatment
plans consistent with evidence-
based practice and patient-specific
factors. In recent years, a dizzying
number of medications have

been introduced to the market

for the management of diabetes;
pharmacists are uniquely positioned
to consider both patient and
medication-related variables and
make recommendations for optimal
drug therapy that incorporate
guidelines and evidence-based
medicine. Tables 1 and 2 provide

a description of commonly used
glucose-lowering agents in the US.

Diabetes Drug Therapies

At the time of initial diagnosis of
type 2 diabetes, most patients
should be initiated on drug therapy
with metformin (in addition to
implementing lifestyle modification)
due to its efficacy, safety, and
accessibility.2 Metformin typically
does not cause hypoglycemia and
has a neutral effect on weight. In
addition, it may have cardiovascular
benefits.? According to the ADA,
metformin is the preferred first line
agent for the management of type
2 diabetes unless patients have
severe symptoms of hyperglycemia
or severely elevated blood glucose
levels (300-350 mg/dL or Alc >10%)
at the time of initial diagnosis, in
which case initial therapy should
include insulin, with or without
metformin.® If starting metformin
therapy, the dose should be titrated
up in order to achieve control of
blood glucose levels; if a patient's
blood glucose remains uncontrolled
after three months, a second agent
should be added to the drug therapy
regimen.® Although the prescribing
information states that metformin
is contraindicated in men with

a serum creatinine >1.5 mg/dL

(>1.4 mg/dL in women), current
evidence supports using metformin
in patients with some degree of
renal impairment, however it should
not be used in patients with an

estimated creatinine clearance
below 30 mL/min?

While metformin is the appropriate
initial therapy for most patients,
the choice of subsequent agents is
less clear and should be tailored to
a specific patient. A sulfonylurea,
thiazolidinedione (TZD), GLP-1
agonist, DPP-4 inhibitor, SGLT2
inhibitor, or basal insulin are all
rational drug therapy options.’ The
choice of a particular agent should
be individualized for each patient
according to its adverse effect
profile, cost, impact on patient
weight, tolerable hypoglycemia risk,
and patient preference.*?

Sulfonylureas have long been
used as add-on therapy in addition
to metformin due to its efficacy in
lowering HbAic. However, unlike
metformin, sulfonylureas are
associated with weight gain and a
risk of hypoglycemia.* In addition,
sulfonylureas may have less efficacy
as diabetes progresses, due to
continued loss of pancreatic beta
cell function. Although similar

to sulfonylureas, meglitinides
may be preferred for patients with
irregular meal patterns or those
who experience post-prandial
hypoglycemia with sulfonylurea
therapy.’ A potential disadvantage
of meglitinides is increased
frequency of dosing compared to
sulfonylureas.°

Thiazolidinediones are another
rational choice for a second agent
in addition to metformin. Like
metformin, it is not associated
with a risk of hypoglycemia, and
its therapeutic efficacy may be
preserved longer than that of
metformin and sulfonylureas.*
However, these agents have been
associated with rare, but serious
adverse effects which may limit its

utility in patients with comorbidities.

Rosiglitazone may be associated
with an increased risk of myocardial
infarction and pioglitazone may be
associated with an increased risk

of bladder cancer.*® Other adverse
effects associated with the TZDs
include weight gain and edema,
which may precipitate heart failure

16 MARYLAND PHARMACIST |! WINTER 2016

exacerbations in those patients at
risks

GLP-1 agonists are injectable
agents, which act by stimulating
insulin secretion, slowing gastric
emptying, promoting satiety and
reducing glucagon secretion.
Advantages of these agents include
its potential to cause weight loss,
efficacy in decreasing post-prandial
glucose, and beneficial impact on
some cardiovascular risk factors.
Potential disadvantages include its
non-oral route of administration,
nausea and vomiting, and a possible
risk of pancreatitis. In addition,
medullary thyroid tumors have been
observed in animal studies.°*?

Similar to GLP-1 agonists, DPP-4
(dipeptidyl peptidase) inhibitors
increase post-prandial incretin levels
by preventing the degradation of
GLP, although with a more modest
HbAtic lowering effect.* Unlike the
GLP-1 agonists, DPP-4 inhibitors
have a neutral effect on weight.

It is generally well tolerated and
does not increase the risk of
hypoglycemia. However, it has been
associated with angioedema and
itching, and may also be associated
with acute pancreatitis or increased
hospitalizations due to heart failure.’

The SGLT2 (sodium/glucose
cotransporter 2) inhibitors are
typically used in combination with
metformin or DPP-4 inhibitors
and have not yet been studied in
combination with GLP-1 agonists.°
Potential advantages of these
agents include its association with
decreases in weight and blood
pressure and lack of hypoglycemia.
However, SGLT2 inhibitors

may cause polyuria leading to
hypotension, increased LDL
cholesterol, and infections of the
genitourinary tract.®

Although not a first line choice,
alpha glucosidase inhibitors
may be used in combination with
metformin. However, its place

in therapy has traditionally been
limited in the United States. The
advantages of alpha glucosidase
inhibitors include its efficacy

Pharmacists can provide patient education
regarding diabetes management ... through
provision of diabetes self-management
education, or DSME, programs.

in controlling postprandial

blood glucose levels, its lack of
hypoglycemia risk, and a potential
cardiovascular benefit.? However,
the modest overall impact on HbAic
lowering, as well as poor patient
tolerance due to adverse effects of
flatulence and diarrhea, has limited
its use.?

Due to the progressive nature

of diabetes, most patients will
eventually require insulin therapy
to maintain blood glucose control.
Typically, insulin therapy is initiated
with a basal insulin which may be
the intermediate-acting neutral
protamine Hagedorn or long-acting
insulin glargine, insulin detemir, or
insulin degludec.® If addition of basal
insulin does not achieve adequate
blood glucose control, particularly of
post-prandial blood glucose levels,
addition of a meal time or prandial
insulin is often required.* Rapid-
acting insulins such as lispro, aspart,
or glulisine are frequently used,

but short-acting human regular
insulin may also be used.® Although
highly effective across all stages

of diabetes, initiation of insulin
therapy is often resisted by patients
and is associated with weight gain,
hypoglycemia risk, and a need for
patient education and training.®

Patient Education

As with any chronic disease,
diabetes requires significant
monitoring and patient education,
which can be successfully provided
by pharmacists. Due to the often
complex medication regimen
required to manage diabetes,
provision of medication counseling
by pharmacists is essential in

order for patients to use their
medications safely and effectively.
In addition to medication therapy,
lifestyle modifications are an
essential component of diabetes
management throughout the course

of the disease. Patients should

be educated to understand that
although diabetes is a progressive
disease, progression may be slowed
through adherence to drug therapy
and lifestyle modifications such as
diet and exercise. Pharmacists are
both willing and able to provide
this patient education. For example,
one study showed over 61.9
percent of pharmacists wanted

to do more patient consultations
and 58.5 percent of pharmacists
stated they wanted to do more drug
management activities.’°

Pharmacists can provide patient
education regarding diabetes
management in a more formalized
manner through provision of
diabetes self-management
education, or DSME, programs.
These courses teach patients
about diabetes management and
what they should know to best
look out for their own progress.
DSME courses must be provided
by a Certified Diabetes Educator;
this credential can be obtained by
pharmacists through completion of
a certificate program."

Conclusion

By maintaining a familiarity

with therapeutic strategies for
managing diabetes and evaluating
the evidence supporting the

use of an ever-increasing array

of agents, pharmacists can help
both patients and primary care
providers effectively manage type

2 diabetes. Pharmacists also have
an important role to play in helping
patients manage this chronic
disease, through patient counseling
on effective medication use and
lifestyle modifications. Pharmacists
with specialized training in diabetes
management may also provide
DSME courses to give patients in-
depth training on self-management
of this chronic disease. @

Sidebar Case

PM is a 56-year-old African
American woman who
presents to her primary care
practitioner's office for her
semi-annual routine visit.
On questioning she states
that she's been feeling “a
triffle pooky” since her last
visit. She says she has less
energy than normal, and she
has a pesky skin infection

in the skin fold under her
abdomen. She's been under
a lot of stress because her
sister was diagnosed with
breast cancer and she’s been
helping take care of her.

The patient lives with her
58-year-old husband;

she prepares their meals
although she’s been busy
with her sister in the past
four months or so that
they have been eating a
lot of frozen dinners. She
acknowledges the frozen
dinners have a lot of salt in
them because she’s often
thirsty after dinner and
during the night. She gets
up once or twice every
night to get a drink of water
and to urinate. The patient
tells you she has to be so
careful about her diet. She
really likes to eat a donut
or bagel for breakfast, but
two hours later she gets
very shaky and her heart
starts to pound. She has to
eat another donut to make
these symptoms dissipate.

PM tells you she isn't
sleeping well because of
the stress in her life and
she needs to get up in the
middle of the night one or
more times.

Continues on next page

MARYLANDPHARMACIST.ORG 17

sidebar Case continued

PMH: e CV: S1, S2 no murmurs/rub appreciated

e Dyslipidemia — 6 months (treated with dietary e Pulm: Clear to Auscultation

modification) mae
e Skin: Fungal skin infection 2 cm x 4 cm right

e Hypertension — 2 years abdomen

¢ Irritable bowel syndrome (diarrhea) Laboratory data (two weeks ago)

e GERD ¢ Random:

¢ Sodium 135 mEq/L; Potassium 4 mEq/L;
Cloride 98 mEq/L; Bicarbonate 26 mEq/L;
Blood urea nitrogen 18 mmol/L; Serum
creatinine 1.1 mg/dL; Glucose 240 mg/dL

Medications:
e Lisinopril 20 mg po qd

e Pepcid Complete — 1 tablet as needed

e Imodium as needed e Hemoglobin Aic = 9.5%

* LDL-C 137 mg/dl; HDL-C 32 mg/dL; TG 220

Go ee ALAR SCL UNCER Nie oe: mg/dl; T cholesterol 227 mg/dl

PE: Laboratory data (one week ago)

e Vital Signs: sitting BP 162/98 HR 84 BPM regular

T: afebrile ¢ Fasting: Glucose 186 mg/dl

¢ HEENT: Dry mucous membranes

You run the Pharmacotherapy Service in this primary care practice and the patient has been referred

to you for management.

1. Can PM be diagnosed with

diabetes?

a. Yes

b. No, she needs to take the
2 hour glucose tolerance
test

c. No, she needs another
fasting blood glucose
drawn

d.No, she needs another Alc
drawn

Yes, PM can be diagnosed with
diabetes mellitus at this point.
She presented with symptoms
suggestive of hyperglycemia
(feeling “a triffle pooky,”

less energy, persistent skin
infections, increased thirst and

urination including nocturia)
and has a random plasma
glucose over 200 mg/dl (240
mg/dl). Her Alc at the time

of presentation also met the
criteria for diabetes diagnosis
(9.5%). A second Alc one week
later was 9.6%, and a fasting
plasma glucose of 186 mg/

dl, which exceeds diagnostic
criteria of a fasting plasma
glucose of 126 mg/dl or higher.

2. What recommendations
would you make for PM at
this time?

a. Lifestyle modification
(weight loss, exercise plan)
b. Metformin 500 mg po bid

18 MARYLAND PHARMACIST | WINTER 2016

c. Glyburide 10 mg po bid
d.A and B
e.A,B and C

According to the ADA
guidelines, PM should
begin lifestyle modifications
immediately, along with
metformin, therefore

the answer is D. PM has

no contraindications to
metformin, and her serum
creatinine is <1.4 mg/dl.

3.Which of the following
values demonstrate PM
has met her metabolic
goals?

continued on page 20

sidebar Case continued

Response Fasting Plasma Glucose Two hour post- c Blood pressure
prandial glucos

Al
90 mg/dl 162 mg/dl 138/84 mmHg
2

Eda 7

[ele selipel 135 mg/dl 210 mg/dl 146/94 mmHg
110 mg/dl 140 mg/dl 130/92 mmHg
aes 60 mg/dl 120 mg/dl 142/94 mmHg

The correct answer is C. The goal fasting plasma glucose is 80-130 mg/dl, 2 hour post-prandial
glucose <180mg/dl, Alc <7% and BP <140/90 mmHg. Only answer C meets all these metabolic goals.

4.Despite the recom- a. Glipizide The correct answer is E — all
mendation you made b.Sitaliptin of the above. Per the ADA
in question 2, PM has * guidelines, any of these agents
not achieved her blood c. Plogliazone may be added to metformin
glucose goal. Which of d Exenatide (and of course continue

the following are possible ON PST A PS lifestyle modifications). Some
options that may be added patients may even progress to
to her regimen? triple therapy. @

Table 1. Overview of Oral Antidiabetics*””

Biguanides Metformin
(Glucophage”)

Mechanism of Adverse Effects
Action

* Decreases hepatic 500mg PO twice daily, Indigestion, flatulence,
glucose production and maximum 2550m<g/day in nausea, vomiting, diarrhea,

intestinal absorption 2-3 doses asthenia, headache

(primary effect)

Vitamin B deficiency

¢ Increases insulin
sensitivity to yield larger

peripheral glucose uptake
(secondary effect)

Lactic acidosis (rare)

Total daily dose Cinitial) = 0.1
- 0.2 units/kg body weight.

Hypoglycemia, injection site
reaction, rash, weight gain

¢ Regulates glucose
metabolism via
decreasing hepatic
glucose production and
stimulating glucose

uptake by skeletal muscle

Insulin (basal) Insulin glargine (Lantus®)

Insulin detemir (Levemir*)

Insulin degludec (Tresiba”)

Titrated to glycemic goal.

Heartburn, nausea,
hypoglycemia, weight gain

2.5-5mg PO once daily,
Max=40mg/day in 1 to 2
divided doses

« Stimulates functional beta
cells in pancreas

Sulfonylureas Glipizide (Glucotrol")

Heartburn, nausea,
hypoglycemia

1.25-5mg PO once daily,
Max=20mg/day in 1 to 2
divided doses

15-30mg PO daily,
Max=45mg/day

A4mg PO daily, Max=8mg/
day

Glyburide (DiaBeta”)

Pioglitazone (Actos")

Rosiglitazone (Avandia”)

Edema, headache, weight
gain, bone fracture, myalgia

Decreases insulin
resistance in liver and
peripheral vasculature

Thiazolidinediones (TZDs)

Severe: Heart failure, liver
failure, Bladder cancer

Continued on next page

MARYLANDPHARMACIST.ORG 19

Table 1. Overview of Oral Antidiabetics®*”* continued

Drug Class Mechanism of Adverse Effects
Action

SGLT-2 Inhibitors Canagliflozin (Invokana”) Blocks glucose 100mg PO daily, Polyuria, vulvovaginal
reabsorption from Max=300mg daily pruritis, genitourinary

Empagliflozin (Jardiance”) proximal renal tubule, infections
leading to increased

glucose excretion 10mg PO daily (Initial); Volume depletion,

Max=25mg once daily hypotension, dizziness

Rare: bone fracture,
diabetic ketoacidosis, renal
impairment Cin patients w/o
renal impairment)

DPP-4 Inhibitors Sitagliptin (Januvia®) Blocks degradation of 100mg PO daily, Hypoglycemia, headache,
incretin hormones by Max=100mg daily nasopharynglitis,
DPP-4 (i.e., GLP) angioedema/urticaria
Saxagliptin (Onglyza”)

5mg PO daily, Max=5mg
daily

GLP-1 Agonist Exenatide (Byetta”) Acts as incretin mimetic; 5mcg SC twice daily a |
Stimulates glucose- :

Liraglutide (Victoza”) dependent release of 0.6mg SC once daily Indigestion, decreased
insulin and suppresses appetite, nausea, vomiting,
secretion of glucagon diarrhea, headache

Acute pancreatitis

C-cell hyperplasia/medullary

thyroid tumors in animals
Meglitinides Repaglinide (Prandin) Inhibits ATP-K+ channel 0.5mg PO two to four times | Hypoglycemia, weight

; ae ae on the membrane of daily before meals (Initial) gain, diarrhea, arthralgia,

Nateglinide (Starlix®) the beta islet cell, which canoe po eaters headache
causes potassium efflux Harta Sth At ties
En teachers times daily before meals
induce insulin secretion (Maintenance)

Max=4mg/dose; 16mg/day
120mg PO three times daily
at 30 minutes before meals

Alpha-glucosidase inhibitors | Acarbose (Precose”) Lowers postprandial 50-100mg PO three times Abdominal pain, flatulence,

glucose by inhibition daily; diarrhea
Miglitol (Glyset”) of pancreatic alpha- Max=100 mg TID (>60kg);
glucosidase hydrolase Max=50 mg TID (< 60 kg)
enzymes in the intestines

Acute pancreatitis

50-100mg PO three times
daily; Max=100 mg three
times daily

Table 2. Classes of Oral Antidiabetics and Major Characteristics®

Drug Class Reduction in HbAlic | Hypoglycemic Risk | Weight Changes | Alpha-glucosidase

1.0-1.5% Neutral Gastrointestinal effects,
lactic acidosis

-1. Low Low
4: Low

Thiazolidinedione 1.0-2.0% Edema, fractures, heart
failure

SGLT-2 Inhibitor 0.5-1.0% Genitourinary effects, High
dehydration

Alpha-glucosidase 0.5-1.0% Neutral Gastrointestinal effects Low

Inhibitors

Low
LOW
Low
Low
Low

HbAic reduction is shown as an average percentage reduction. Weight gain is signified by a +, while weight loss is
signified by a -. The cost column is designated by low (cost <$100) moderate (cost $100 to $199) and high (cost
>$200) in regards to the wholesale acquisition cost for a 30-day supply.

20 MARYLAND PHARMACIST | WINTER 2016

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CONTINUING EDUCATION QUIZ

PharmCon is accredited by
the Accreditation Council
for Pharmacy Education as
a provider of continuing
pharmacy education. A
continuing education credit
will be awarded within six to eight weeks.

Program Release Date: 1/19/2016
Program Expiration Date: 1/19/2019

The authors have no financial disclosures (2) Scroll down to Homestudy/
to report. OnDemand CE Credits and select the

This program is Knowledge Based — OB ee

acquiring factual knowledge that is based (3) Login using your username (your
on evidence as accepted in the literature email address) and Password

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change your password after logging
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(4) Click the Test link to take the quiz.

Directions for taking this issue's quiz:

This issue’s quiz on Management of Type
2 Diabetes: Review of Drug Therapy and

This program provides for 1.0 contact
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credit. Universal Activity Number (UAN)
0798-9999-16-003-HO1-P

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References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States. 2014. Available
from: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed December 15, 2015.

2 American Diabetes Association. Statistics About Diabetes. 2015. Available from: http://www.diabetes.org/diabetes-basics/statistics/. Accessed December
152015;

3. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the

American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012;55:1577-1596.

Zhuo X, Zhang P, Barker L, et al. The lifetime cost of diabetes and its implications for diabetes prevention. Diabetes Care 2014'37:2557-2564.

American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care 2016;39(Supplement 1):S13-S20.

American Diabetes Association. Glycemic targets. Diabetes Care 2016;39(Supplement 1):S39-S46.

American Diabetes Association. Cardiovascular disease and risk management. Diabetes Care 2016;39(Supplement 1):S60-S71.

American Diabetes Association. Approaches to glycemic treatment. Diabetes Care 2016;39(Supplement 1):S52-S59.

Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position

statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015;38:140-149.

10. Mott DA, Doucette WR, Gaither CA, Pedersen CA, Schommer JC. Pharmacist's attitudes toward worklife: results from a national survey of pharmacists.
J Am Pharm Assoc 2004; 44:326-336.

11. National Certification Board for Diabetes Educators. Certification Information. 2015. Available from: http://www.ncbde.org/certification_info/. Accessed
December 15, 2015.

12. Truven Health Analytics. Micromedex® Solutions. 2015. Accessed December 15, 2015.

13. Pharmacist’s Letter. Drugs for type 2 diabetes. Pharmacist's Letter 2012;28:280805. Available from: http://pharmacistsletter.therapeuticresearch.com/pl/
ArticleDD.aspx?nidchk=18cs=6s=PL&pt=28segment=46208dd=2808056AspxAutoDetectCookieSupport=1. Accessed December 7, 2015.

WOONAMA

MARYLANDPHARMACIST.ORG 21

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I AM GRATEFUL for the
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MPhA community including
Staff, elected leaders and
trustees, Past Presidents,
Deans, committee chairs,
MPhA members, corporate
sponsors, and partners who
have shared their vision, the
history and dreams for MPhA.
Thank you for investing
your time and expertise

and allowing me to visit
your practice settings and
campuses.

Congratulations to the many
members who were involved for nearly a decade in identifying
the right location and design for MPhA’s home in Columbia,
Maryland. We continue to receive positive
feedback from visitors on the facilities and
location. If you haven't visited yet, the door
is open!

VISION

In 2015 the Board of Trustees asserted

its vision for MPhA to be the voice
representing all Maryland pharmacists as
innovative and respected members of the
healthcare team focused on the health
and well-being of Maryland residents. In
order to achieve this vision, priority areas
were identified in the areas of Governance,
Membership Value, and Recruitment and
Retention. Our mission is to strengthen
the profession of pharmacy, advocate for
all Maryland pharmacists and promote
excellence in pharmacy practice.

A few highlights of how we are doing:

e Aligning MPhA Governance to facilitate organizational
growth and pharmacy community engagement

o In September 2015, the Board of Trustees approved MPhA‘s
cultural core (our vision, mission and values).

o In January 2016, the Board Composition Task Force
presented recommendations to the Board of Trustees
related to nomination and election policies and procedures
as well as composition and representation on the Board of
Trustees,

oO Operational structure and facilities in place that will
continue to support and enhance the ability of MPhA to
collaborate with strategic partners.

e Enhancing Membership Value, proposition in the areas
of advocacy, communication, continuing education,
networking, and professional development/visibility.

oO MPhA was fully engaged in the 2015 legislative session,
actively participating in the passage of two Maryland
Pharmacy Coalition bills that advanced and enhanced

Executive Director’s Message

“As | reflect on 2015, it is
gratifying to be at the helm of
an organization that is growing
and changing to meet the
needs of today’s pharmacists,
student pharmacists, residents
and pharmacy technicians.
Collectively, we have navigated
through opportunities and

challenges presented to our © MPhA collaborated with the MPhA
community in 2015.”

pharmacist scope of practice as well as emergency
legislation designed to address pharmacy network
restrictions.

oO MPhA has hired a lobbying firm to assist in building our
recognition in Annapolis and forge relationships with
elected leaders to advance MPhA legislative priorities

o Communications, Professional Development and
Membership Committees are working collaboratively to
enhance MPhAss social media presence and to provide
avenues for membership activity that address leadership,
innovative practice, professional excellence and the
collegiality of our organization.

o Board meetings are now held bi-monthly with CE activities
and membership events on the off months.

o The Monday Message following the Board of Trustees
Meetings includes meeting highlights and updates.

o An online Membership Directory is
now available on our website, which
gives you the ability to connect with
new and old colleagues, classmates
and friends.

o MPhA Meetings Committee
launched a call for abstracts for
the Annual Convention to ensure
meeting content highlights diverse
speakers and innovative content.
Submit your topics and encourage
others to as well. You can find the
link in the Monday Message or on
our website.

Foundation and various state
agencies and national organizations
to bring you Point-of-Care Training
and leadership workshops as well as a newly implemented
Health Information Exchange Task Force and collaborations
on the Naloxone Standing Orders.

« Increase Pharmacist Community Membership
Recruitment and Retention

o Initiated the Pharmacists Month video contest and
membership CE and recruitment drive.

o Established new member benefits for financial education/
webinars, loan consolidation, and Drug Security Supply
Chain Act compliance.

o MPhA leadership is conducting focus groups and outreach
within different regions in the state and practice settings.
Stay tuned for when we come to you!

There's much more to come. Cheers to an innovative and
productive 2016! @

Aliyah N. Horton, CAE
Executive Director

MARYLANDPHARMACIST.ORG 23

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MPhA News Provider Status Continuing Education University of Maryland

| An update on the 2016 Mid- Why provider status is Article School of Pharmacy
Year Meeting, 16th Annual MPC important, what it means A Review of Abuse-Deterrent Celebrating its 175th
Legislative Day, MPhA’s Open and why we're working so Opiod Formulations and Anniversary

| House, and APhA’s Annual

Place in Therapy
| Meeting & Exposition

hard to achieve it locally
and nationwide

SPRING 2016

Provider
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Do you have a HIPAA P&P manual/program in place?
Has your Notice of Privacy Practice been updated since
July 1, 2013?

Do you maintain a breach assessment when the patient
receives another patient’s medication?

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Contents

COVER STORY
Provider Status

We talk a lot about the idea of pharmacists having “provider status.”
But what exactly does that mean? Georgia Pharmacy Association
CEO Scott Brunner sat down with Krystalyn Weaver, PharmD, the
vice president of policy and operations for the National Alliance

of State Pharmacy Associations, to talk about that phrase — why
provider status is important, what it means and why we're working
so hard to achieve it locally and nationwide.

5
President’s Pad

8
Advocacy
2016 Legislative Session Report

Editorial

11 | University of Maryland School of Pharmacy
Celebrates 175th Anniversary

16 | The Role of Ethics in Pharmacy

19
Maryland Colles i; Phaniacy Continuing ed
Building erected in 1886 2 EA SUZ

27
Executive Director’s Message

ADVERTISERS INDEX

25 Corporate Sponsors

2 RJ. Hedges & Associates Winter 2016 Correction
4 Cardinal Health The primary author was listed incorrectly on A ¢ ollab« ration
: to Enrich the Future Leaders of Maryland Pharmacy. Shannon
18 Pharmacists Mutual Riggins, PharmD Candidate 2017 University of Maryland Eastern
25 Buy-Sell-A-Pharmacy Shore School of Pharmacy is the primary author. James |
26 HD Smith Bressette, PharmD is the secondary author

28 University of Maryland
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President’s Pad

Dear Fellow MPhA Members,

Thank you for accepting my “ask” or invitation for you to be engaged
with MPhA this past year. Thank you for embracing our theme

of “Ask Me 2 about MPhA’ and getting involved. And thank you

for reminding our patients to “Ask your pharmacist about your
medications.”

It has been an amazing, enjoyable, and very fast-paced year.

I believe we have achieved our goals and plans, which would

not have happened without each of you. As I write my fourth
president's message, it is appropriate to reflect upon our collective
achievements in carrying out our mission and implementing the
2016 strategic plan, as well as upon ongoing efforts of the 20+

committees, taskforces, and networks from June 2015 to May 2016.

Together we implemented the 2016 strategic plan with priorities in governance, membership
retention and recruitment, and membership value proposition including advocacy,
communications, continuing education, networking, and professional development/visibility

Revised and recommended changes in by-laws as approved by the Board of Trustees in
March 2016 and to be discussed/voted on at the House of Delegates at the convention

Engaged members by changing the monthly Board of Trustees meetings to bi-monthly to
facilitate bi-monthly membership programs:

o American Pharmacists Month Celebration with Medication Safety CE in October 2015
oO Holiday Party in December 2015

o Advocacy Workshop in February 2016

o New Practitioners Workshop in April 2016

Moved to the new Headquarters in Columbia, secured a tenant in the additional building
suite, and hosted an Open House

Had a successful Mid-Year Meeting in Columbia on January 31, 2016

Enhanced the Maryland Pharmacist journal to all-color starting with the Winter 2016 issue
Collaborated with the Maryland Pharmacy Coalition (MPC) to advocate for pharmacy-related
bills during the 16th Annual MPC Legislative Day on February 18, 2016 and throughout the
2016 legislative session

Organized three regional outreach CE programs and focus groups/surveys:

o Eastern Shore MD hosted by Eastern Shore Pharmaceutical Society on February 21, 2016

o Central MD hosted with Primary Care Coalition of Montgomery County on March 10, 2016
o Western MD hosted with Quad State Pharmacy Association on April 27, 2016

Collaborated with the three schools of pharmacy to host a record breaking Maryland
Pharmacy Night Reception during APhA‘s Annual Meeting in Baltimore, March 5, 2016. Over
400 guests attended and networked together

Launched the Federal Pharmacy Network with a reception at the Food and Drug
Administration on March 16, 2016

Coordinated a Script Your Future Medication Adherence event on April 27, 2016

Conducted two visits to the U.S. Capitol Hill on March 30, 2016 and April 29, 2016 to advocate
and thank legislators for their support of pharmacists’ provider status bills and efforts
Collaborated with the MPhA Foundation to present student scholarships and awards for grad-
uates at the three schools of pharmacy graduations

Facilitated the Board's approval to be an affiliate organization with the Academy of Manage
Care Pharmacists

With numerous initiatives and programs throughout the year, it would not be possible to
recognize all individual volunteers on committees, taskforces, and networks in this message.

It has also been so valuable to have partners such as the MPhA Foundation, three schools of
pharmacy, and our corporate sponsors. We could not have done it without each of you. I thank
you and look forward to celebrating with you during our Annual Convention in Ocean City.

I still need you. MPhA still needs you. Our pharmacy profession still needs you. Please continue
to be engaged and invite fellow pharmacists, student pharmacists, and technicians to be
involved. As I pass the torch to incoming MPhA President Kristen Fink, it continues to be an
exciting time with great momentum for MPhA and pharmacy. I am confident you will support
her as you have supported me. It has been and continues to be an exciting journey for us to
serve together. I sincerely thank you for allowing me to serve as your 2015-16 President. @

Sincerely,

hai Aw
Hoai-An Truong, PharmD, MPH, FNAP
President

i ARRAACS

PART LAW,
Noni’

‘7.198% = MARYLAND PHARMACISTS ASSOCIATION

MANAGING EDITOR
Kelly Fisher

MPhA OFFICERS 2015-2016

Dixie Leikach, RPh, MBA, FACA,
Chairman

Hoai-An Truong, PharmD, MPH, FNAP
President

Kristen Fink, PharmD, BCPS, CDE, Vice
President

Matthew Shimoda, PharmD, Treasurer

Thomas Menighan, BS Pharm, MBA, ScD,
FAPhA, Honorary President

HOUSE OFFICERS

W. Chris Charles, PharmD, BCPS, AE-C,
Speaker

Ashley Moody, PharmD, BCACP., AE-C,
Vice Speaker

MPhA TRUSTEES
Nicole Culhane, PharmD, BCPS, FCCP.
~ 2016
Mark Lapouraille, RPh, 2016
Cherokee Layson-Wolf, PharmD, CGP,
BCACP, FAPhA, 2017
G. Lawrence Hogue, BSPharm, PD, 2017
Wayne VanWie, RPh, 2018
Chai Wang, PharmD, BCPS, AE-C, 2018
Shannon Riggins, ASP Student President
University of Maryland Eastern Shore
School of Pharmacy

PEER REVIEWERS

W. Chris Charles, PharmD, BCPS, AE-C

Caitlin Corker-Relph, MA, PharmD
Candidate 2017

Nicole Groves, PharmD

G. Lawrence Hogue, BSPharm, PD

Edward Knapp, PharmD, PhD

Hanna Salehi, PharmD, MLS

STAFF

Aliyah N. Horton, CAE, Executive
Director

Kelly Fisher, Marketing Coordinator

Shawn Collins, Membership Services
Coordinator

We welcome your feedback and

ideas for future articles for Maryland
Pharmacist. Send your suggestions to
Aliyah Horton:

Maryland Pharmacists Association, 9115
Guilford Road, Suite 200, Columbia,

MD 21046, call 443.583.8000, or email
aliyah.horton@mdpha.com.

Special thanks to Graphtech, Advertising
Sales and Design

What has MPhA been doing?
Member Mentions highlighted below!

16th Annual MPC Legislative Day

MPhA participated in the 16th Annual Maryland Pharmacy Coalition (MPC) Legislative Day on February 18, 2016.
Legislative Day is the centerpiece of MPC's effort to send a unified pharmacy message to Maryland state legislators.
This annual event is instrumental in advancing the pharmacy profession and facilitates pharmacists and student
pharmacists in educating legislators on the importance of pharmacists and how we improve healthcare for our
patients. Legislative Day consistently brings together over 300 participants who represent nearly all of the Maryland

legislative districts and pharmacy practice settings.

The meeting kicked off with opening remarks by Senator John Astle (D-30). This year, MPC focused on issues relating
to appropriate use of controlled substances by patients in Maryland, among many other pharmacy-related bills.

MPC representatives from each organization developed consensus statements on pharmacy related bills that were
introduced at that time. For specific legislative updates, please see page 8.

Student pharmacists with
Carlo Sanchez, Member
of Maryland House of
Delegates, Prince George’s
County

Thank you to all the
student pharmacists

for advocating for your
profession and making sure
your voices are heard!

2016 Mid-Year Meeting

MPhA held its annual Mid-Year Meeting on January 31,
2016 at the DoubleTree Hilton in Columbia, Maryland. It
was a full-day of live continuing education, networking,
and professional recognition!

Continuing education sessions included hot topics
such as:

¢ Medication safety (See page 16 for a follow up on the
Role of Ethics in Pharmacy)

¢ Maryland's naloxone state-wide standing order
information and implementation

¢ Pharmacy legislative and advocacy updates

¢ Clinical updates on biosimilars and medicinal cannabis

6 MARYLAND PHARMACIST | SPRING 2016

Executive Director Aliyah
Horton and President
Hoai-An Truong with
Pete Hammen, Chair of
the House Health and
Government Operations
Committee

Executive Director Aliyah
Horton and President
Hoai-An Truong with Mac
Middelton, Chair of the
Senate Finance Committee

President Hoai-An Truong presented Kim Morris with
MPhA's 2016 Pharmacy Technician of the Year Award
for her significant contributions to the expanding role

of the pharmacy technician. Kim has been a pharmacy
technician at Finksburg Pharmacy for over ten years.

He also presented MPhA’s 2015 Honorary President
award to Thomas Menighan, American Pharmacists
Association Executive Vice President and Chief Executive
Officer. Tom is a long-time MPhA member and resident
of Maryland who has made a career of significantly
contributing to the pharmacy profession. MPhA was
pleased to work with him and APhA staff to support their
Annual Meeting held in Baltimore.

Wivirn

WiVviln

Kim Morris accepting
her award with MPhA
members, Finksburg
Pharmacist Manager Rai
Cary and Owner Dixie
Leikach

Thomas Menighan
accepting his award with
Executive Director Aliyah
Horton and President
Hoai-An Truong

@MPhA @MPh\ OMPhA @

MPhA’s Open House

On February 20, 2016, MPhA welcomed members

and partners at our Official open house and ribbon
cutting ceremony at our headquarters in Columbia,
Maryland. President Hoai-An Truong presented

Murhl Flowers, Relocation Committee Chair, and

Matt Shimoda, Building Committee Chair, with a
certificate of recognition for their outstanding generosity,
dedication, and leadership to MPhA. Murhl and Matt
were instrumental in getting MPhA a secure, centralized,
and charming location that will support the needs of
MPhA now and in the future. Thank you to everyone
who came and celebrated our new home with us.

Ribbon cutting time!

(left to right) Executive
Director Aliyah Horton,
Treasurer and Building
Committee Chair Matt
Shimoda, Relocation and
History Committee Chair
Murhl Flowers, MPhA
Foundation President
Paul Holly, and President
Hoai-An Truong

Thank you to our

Past Presidents!

(back, left to right) Neil
Leikach, Phil Cogan, Murhl
Flowers, Paul Holly, Matt
Shimoda, Howard Schiff,
Current President Hoai-An
Truong, Butch Henderson
(sitting, left to right) Dixie
Leikach, Christine Lee-
Wilson, Jean Freels

@MPh @MPh @MPhA

APhA’s Annual Meeting & Exposition

The American Pharmacists Association (APhA) held

its Annual Meeting and Exposition on March 4-7 2106
in Baltimore, Maryland. Several MPhA members were
recognized with awards and appointments! It was great
seeing MPhA members recognized on a national level
for their pharmacy efforts and having a strong Maryland
presence throughout the meeting!

(left to right) APhA CEO Thomas Menighan, Executive Director Aliyah
Horton, Past President Cynthia Boyle, Congressman Elijah Cummings,
President Hoai-An Truong, University of Maryland School of Pharmacy
Dean Natalie Eddington, Past President Magaly Rodriguez de Bittner

Source: American Pharmacists Association

e ASP President Elissa Lechtenstien from the University
of Maryland School of Pharmacy was elected APhA-
ASP Member-at-Large. Elissa was also recognized as a
recipient for the 2016 APhA Foundation’s Mary Louise
Andersen Scholarship.

e Salematou Traore from University of Maryland Eastern
Shore School of Pharmacy was recognized as the
recipient for the 2016 APhA Foundation’s Mary Munson
Runge Scholarship.

e Carolyn Cooper from the University of Maryland
Eastern Shore School of Pharmacy was selected
as arecipient of the Ron Williams Memorial Fund
Scholarship.

e Past President Butch Henderson was recognized as
the 2015 Bowl of Hyegia Award recipient

e Trustee Cherokee Layson-Wolf was honored with the
APhA-ASP Outstanding Advisor Award.

e Joey Mattingly was nominated as candidate for
speaker-elect of APhA’s House of Delegates

e Notre Dame of Maryland University School of
Pharmacy was recognized with the Outstanding IPSF
Activity Award.

e University of Maryland School of Pharmacy APhA-
ASP Chapter won second runner up of the Division A
Chapter Achievement Award.

MARYLANDPHARMACIST.ORG 7

2016 Legislative Session Report

The 436th session of the Maryland General Assembly adjourned sine die at midnight on April 11, 2016 after 90 days
of meetings to consider more than 2,800 bills and resolutions. By contrast, last year only roughly 2,200 bills were
submitted making this a very busy year with committees meeting well into the evening and late night hours to

review legislation.

Major Topics

Each year there are a few topics
that dominate the debate in
Annapolis. Below you will find more
information on some of the major
topics debated this session. These
topics cover only a small fraction of
the total legislation considered.

Justice Reinvestment Act

After debate over the entire
legislative session, a bill was passed
on the final day will change how
criminal justice is adrninistered

in the state. The bill includes

a provision that removes the
mandatory minimums for providing
bogus prescriptions but sets
maximum sentences of 20 years
for the first and second offenses,

25 years for the third and 40 years
for the fourth.

Drunk and Drugged Driving

The most debated bill on this topic
went by the name of “Noah's Law”
in memory of Montgomery County
Police Officer Noah Leotta who
was killed by a drunk driver late last
year. The legislation would require
ignition interlock devices in the
cars of all drunk driving offenders.
Noah's Law passed on the final

day of the legislative session after
lengthy debate about the details of
implementation of the bill.

Earned Sick Leave

For supervisors and business
owners, earned sick leave has been
introduced without successful
passage for several years. This year,
for the first time, it was passed in
the House of Delegates. The Senate
vote came down to the final hours
of the legislative session with the
bill ultimately not passing. The bill
would require that all companies
with more than 14 employees
provide earned sick leave at a rate
no less than one hour per every
thirty hours worked.

Prescription Drug Monitoring
Program

Legislation was passed that

will create a prescription drug
monitoring program to help curb
the over-prescription of opiates
and other narcotics. This is part of
a number of bills aimed at reducing
the illegal drug use epidemic in
the state, a priority of the Hogan
Administration. MPhA worked to
remove pharmacist requirements
for mandatory querying prior to
dispensing. The bill does require
pharmacists to be registered in the
system. A more substantive review
of the bill will be provided in future
publications.

MPhA INTERIM ACTIVITIES

G.S. Proctor & Associates was
committed to assuring MPhA‘s
advocacy participation with
our legislative priorities during
the 2016 legislative session —

8 MARYLAND PHARMACIST | SPRING 2016

Prescription Drug Monitoring
Program legislation, specialty

drugs legislation and other related
bills. They are working to assure
future successes by establishing
relationships with key officials
during the interim. G.S. Proctor
committed meetings for MPhA‘s
Executive Director to meet with
Delegate Nic Kipke (specialty drugs
bill sponsor), Senator Mac Middleton
(PDMP bill sponsor), House Speaker
Michael E. Busch, Senate President
Mike Miller and Brian Frosh, Attorney
General. These meetings will allow
MPhA to provide information on
issues and concerns and share
legislative and regulatory priorities.

MPhA BILL UPDATE

The following chart includes bills
reviewed by MPhA‘’s Advocacy
Committee and tracked by G'S.
Proctor & Associates during the 2016
Legislative Session. If there were
bills in the 2016 legislative session
that you believe MPhA should
have tracked or taken a position
on, you are encouraged to join the
Advocacy Committee and provide
your insight and perspective. Just
add the Advocacy Committee in
your member profile. If you need
assistance, please contact MPhA at
443-583-8000.

Status 2016 Regular Session

Primary Status

Sponsor
Unfavorable
Unfavorable

Returned Passed

HBO015 Harford County—Suspected Overdoses—Reporting Requirement Requiring
specified individuals who treat or are in charge of a hospital that treats an individual in
Harford County for a suspected overdose that was caused or shows evidence of having
been caused by a Schedule I controlled dangerous substance to notify the county sheriff,
county police, or the Department of State Police of the suspected overdose within 48
hours after the individual is treated; requiring that a report of a suspected overdose
include specified information; and establishing a specified penalty.

Delegate Szeliga

HB0024 Public Health—Overdose Response Program—Educational Training Program
Requirement Requiring educational training for an Overdose Response Program overseen
by the Department of Health and Mental Hygiene to include training in the requirement
to immediately contact medical services after the administration of naloxone by a
certificate holder instead of training in the importance of contacting emergency medical
services.

Delegate Szeliga

HB0104 Medical Cannabis—Written Certifications—Certifying Providers Authorizing
specified dentists, podiatrists, nurse midwives, and nurse practitioners, in addition

to physicians, to issue written certifications to qualifying patients by substituting the
defined term ‘certifying provider" for “certifying physician” as it relates to laws governing
medical cannabis; establishing that specified providers must be in good standing with
the regulatory board regulating the licensing and certification of specified providers;
providing for a delayed effective date; etc.

Delegate Morhaim

eliminate mid-wives—
amendment was rejected

Unfavorable

HBO0006 Criminal Law—Improper Prescription of Controlled Dangerous Substance
Resulting in Death Prohibiting an authorized provider from prescribing, administering,
distributing, or dispensing a controlled dangerous substance to a person if such practice
is not in conformity with specified provisions of law and the standards of the authorized
provider's profession relating to controlled dangerous substances and the person's use or
ingestion of the controlled dangerous substance is a contributing cause of the person's
death; establishing penalties of up to 20 years in prison or a fine of up to $100,000 or
both; etc.

HBO117 (SB0469) State Board of Pharmacy—Licensure Requirements for
Pharmacists—Proof of Proficiency in English Providing that, for applicants for a license
to practice pharmacy, graduation from a recognized English-speaking professional school
accredited by the Accreditation Council for Pharmacy Education is acceptable proof of
proficiency in the oral communication of the English language.

HB0437 (SB0537) Department of Health and Mental Hygiene—Prescription Drug
Monitoring Program—Modifications Requiring that specified authorized providers

and prescribers be registered with the Prescription Drug Monitoring Program before
obtaining a new or renewed controlled dangerous substance registration or by July 1,
2017, whichever is sooner; requiring that pharmacists be registered with the Program by
July 1, 2017; altering the mission of the Program; authorizing the Secretary of Health and
Mental Hygiene to identify and publish a list of monitored prescription drugs that have
low potential for abuse; etc.

Delegate Young, K.

Returned Passed

Delegate Barron

Delegate Barron Returned Passed

Meetings to combine
language with Gov’s Bill
SB537—pg 7 lines 14-18
pharmacist language
removed,

Unfavorable

Unfavorable
Unfavorable

Continued on page 10

HB1241 Pharmacy Benefits Managers—Contracts With and Reimbursement of Delegate Kipke
Pharmacists Requiring each initial and renewal contract between a pharmacy benefits
manager and a contracted pharmacy to include the sources used to determine
maximum allowable cost pricing; requiring a pharmacy benefits manager to update

its pricing information at specified intervals and for a specified purpose; specifying the
format in which pricing updates must be provided by a pharmacy benefits manager to a
contracted pharmacy; etc.

HB1i242 Pharmacy Benefits Managers—Reimbursement and Pharmacy Choice Delegate Kipke
Prohibiting a pharmacy benefits manager from reimbursing a pharmacy or pharmacist
for a pharmaceutical product or pharmacist service in a specified amount; authorizing a
pharmacy or pharmacist to decline to provide a pharmaceutical product or pharmacist
service to an individual or pharmacy benefits manager under specified circumstances;
prohibiting a pharmacy benefits manager or health benefit plan from imposing specified
conditions on an individual or covered entity under specified circumstances; etc.

HB1347 Maryland Medical Assistance Program—Managed Care Organizations— Delegate Kipke
Disenrollment Authorizing a Maryland Medical Assistance Program recipient, under
specified circumstances, to disenroll from a managed care organization to maintain
continuity of care with a pharmacy provider; requiring the Department of Health and
Mental Hygiene to provide timely notification to the affected managed care organization

of an enrollee’s intention to disenroll under specified provisions of the Act; etc.

MARYLANDPHARMACIST.ORG 9

HB1383 (SB1018) Health Insurance-Specialty Drugs—Participating Pharmacies Altering
the conditions under which insurers, nonprofit health service plans, or health maintenance
organizations may require a covered specialty drug to be obtained through a pharmacy
participating in the provider network of the insurer, nonprofit health service plan, or health
maintenance organization; altering the definition of “specialty drug”; etc.

HBO752 (SB0647) Physicians—Prescriptions Written by Physician Assistants—Preparing
and Dispensing Providing that specified provisions of law do not prohibit a licensed
physician from personally preparing and dispensing a prescription written by a physician
assistant in accordance with a specified delegation agreement if the physician complies
with specified requirements.

HB0826 Prescription Drug Repository Program—Repository Inventory Requirement
—Revision Requiring a repository that participates in the Prescription Drug Repository
Program to maintain a separate inventory of donated prescription drugs and medical
supplies that the repository intends to dispense under a specified provision of law, instead
of a separate inventory of all donated prescription drugs.

$B0091 Public HealthState—Identified HIV Priorities Requiring rebates received by

the Department of Health and Mental Hygiene from the Maryland AIDS Drug Assistance
Program as a result of State General Fund expenditures to be distributed to a specified
special nonlapsing fund and used only to fund State-identified priorities for HIV
prevention, surveillance, and care; requiring the Secretary of Health and Mental Hygiene to
adopt regulations establishing, as appropriate, income and other eligibility criteria for the
receipt of specified HIV prevention and care services.

SB0806 State Board of Physicians—Naturopathic Doctors—Establishment of
Naturopathic Doctors Formulary Council and Naturopathic Formulary Establishing a
Naturopathic Doctors Formulary Council within the State Board of Physicians; providing
for the membership, terms, compensation, chair, and staff for the Council; requiring the
Council to develop and recommend to the Board a specified formulary, provide specified
reviews of the formulary, and make specified recommendations to the Board; requiring
the Board to adopt a specified formulary; etc.

HB0056 (SB0063) Investigational Drugs, Biological Products, and Devices—Right to Try
Act Authorizing a manufacturer of an investigational drug, biological product, or device to
make available the investigational drug, biological product, or device to eligible patients;
specifying the manner in which a specified drug, product, or device may be provided

to eligible patients; prohibiting a health occupations board from taking specified action
against a health care provider's license on a specified basis; establishing that this Act does
not create a specified cause of action; etc.

HBO091 (SB0442) General Provisions—Commemorative Days—National Healthcare
Decisions Day Requiring the Governor annually to proclaim April 16 as National
Healthcare Decisions Day.

$B0418 (HB0404) Richard E. Israel and Roger “Pip” Moyer End-of-Life Option Act—
Authorizing an individual to request aid in dying by making specified requests; prohibiting
another individual from requesting aid in dying on behalf of an individual; requiring a
written request for aid in dying to meet specified requirements; establishing requirements
for witnesses to a written request for aid in dying; requiring a written request for aid in
dying to be in a specified form; requiring an attending physician who receives a written
request for aid in dying to make a specified determination; etc.

10 MARYLAND PHARMACIST | SPRING 2016

Primary
Sponsor

Delegate Kipke

Delegate Cullison

Delegate Adams

Chair, Finance
Committee

Senator
Pugh

Delegate Young, K.

Delegate Morhaim

Senator Young

Status

Unfavorable

Returned Passed

Unfavorable

Approved by the
Governor— Chapter 46

Returned Passed

Unfavorable

Returned Passed

Unfavorable
Withdrawn

University of Maryland School
of Pharmacy Celebrates
175th Anniversary

By: Malissa Carroll

A reflection on how the School continues to be one of the leaders in pharmacy
education, scientific discovery, patient care, and community engagement across the
state of Maryland and beyond.

Visiting the University of Maryland School

of Pharmacy today, one cannot help but
notice some bold changes in the decor

both inside and around Pharmacy Hall. New
signage along Pine and Fayette Streets, as
well as colorful wrappings on the poles,
stairs, and elevators in the Ellen H. Yankellow
Grand Atrium signify the commemoration

of an important milestone in the School's
history. It is the School's 175th anniversary,
and throughout 2016, faculty, staff, students,
alumni, and friends are celebrating its nearly
two centuries of leadership in pharmacy
education, scientific discovery, patient care,
and community engagement across the state
of Maryland and beyond.

one

reyes = 8: Sasa

Maryland College of Pharmacy
Building erected in 1886

“This remarkable milestone in the School of
Pharmacy’s history could not have come

at a more opportune time, as health care professionals and policymakers

alike begin to recognize the essential role that pharmacists play in the nation’s health care delivery system,” says Jay
A. Perman, MD, president of the University of Maryland, Baltimore (UMB). “With cutting-edge practice and research
initiatives in the fields of drug discovery, drug development, and drug delivery, the School makes a tremendous impact
not only on the pharmacy profession, but also on patients’ lives. It is what the School has done for 175 extraordinary
years, and what I hope it will continue to do for many more years.”

From Humble Beginnings

Established in 1841, the School of Pharmacy was first known as the Maryland College of Pharmacy. It was initially
chartered by the Maryland General Assembly in response to concerns from practicing apothecaries about the need
for more educated and better trained pharmacists and pharmaceutical assistants to address the increasing number
of medicines available to treat different illnesses. Before gaining recognition as a thriving center for professional and
graduate education, pharmaceutical care, research, and community service, the School's first class included only six
students and was held in a single room at the corner of Gay and Baltimore Streets.

Now ranked as one of the top ten schools of pharmacy in the United States, the School boasts more than 90 faculty,
300 staff, 700 students across its Doctor of Pharmacy (PharmD) and graduate programs, and 5,500 living alumni.

Continued on page 17

MARYLANDPHARMACIST.ORG 11

Cover Story

Provider Status

We talk alot about the idea of pharmacists having “provider status."
But what exactly does that mean? Georgia Pharmacy Association
CEO Scott Brunner sat down with Krystalyn Weaver, PharmD, the vice
president of policy and operations for the National Alliance of State
Pharmacy Associations, to talk about that phrase — why provider
status is important, what it means and why we're working so hard to

achieve it locally and nationwide.

Across practice settings, provider status is seen as
the great brass ring for pharmacists. So let's start by
defining the term: What is provider status, and why
do we need it?

Today the federal government does not recognize
pharmacists as medical “providers” — specifically in
Part B of the Social Security Act. That means Medicare
beneficiaries aren't able to access pharmacists’ patient-
care services such as diabetes management, smoking
cessation assistance, and even simple wellness visits
through their Medicare benefits.

Hence our goal of attaining federal “provider status.” A
major step of that would be passage of the Pharmacy
and Medically Underserved Areas Enhancement Act,
aka H.R. 592 or S.314. It would allow Medicare to pay for
pharmacists services in medically-underserved areas.

But if you dig into the “why’ of that objective, it’s more
than just about pharmacists. It’s about the fact that
patients benefit from the valuable services pharmacists
can provide. We know that when pharmacists are on the
healthcare team, outcomes improve and costs go down.

To sum it up, the goal is to ensure that patients’ have
access to pharmacists’ brains — not just the products we
dispense.

Back to the term provider status. Medicare access is

a major step, but it’s only the first step. The reality is

that we need to approach ensuring patient access to
pharmacists services from more than one angle. Though
Medicare patients make up a huge population of those
who would benefit from pharmacist’s knowledge and
skills, there are many other patients who do not have
Medicare coverage.

12 MARYLAND PHARMACIST | SPRING 2016

This interview first appeared in
Georgia Pharmacy magazine.

Krystalyn Weaver, PharmD

So “provider status” is broader. It encompasses any effort
to get patients access to these services, which makes the
meaning of that term somewhat complicated.

Add to that the fact that not every pharmacist wants

to provide those services. Often when I'm talking

about integrating more patient-care services into Our
practices, I get the inevitable comment: ‘I'm too busy

in the pharmacy as it is. There is no way I can add even
more activities to my day-to-day operations and still get
prescriptions filled.”

As a practicing community pharmacist myself (although
it's only moonlighting), I can relate. Any pharmacist

(or consumer for that matter) knows how busy a
community pharmacy can be. It is, in fact, difficult to add
to that workload in the world we live in now.

But that’s the key phrase: In the world we live in now. It
doesnt have to be this way.

I challenge my peers not to think of the current practice
environment. When were talking about broadening
pharmacists’ services, think of the future. Remember
that the reason we aren't already doing this is because
Our payment system is broken — it doesn't recognize
the value pharmacists are capable of providing. A core
premise of the provider status push is that we have

to change our business model. We need to change

the practice environment and make it feasible for our
services to be delivered effectively.

We are talking about overhauling our workflow so
patient-care services become a focus, not an add-on.
And yes, we're talking about new streams of revenue.

I would also argue that considering the ever increasing
pressures to decrease what Americans pay for

prescription drugs, that a change in our business
model is likely essential for pharmacies to survive. Any
pharmacy owner can attest to the fact that margins are
decreasing. In order to keep pharmacist jobs viable, we
need to leverage our most valuable asset: our ability

to optimize medication regimens, assist patients with
disease management and prevention, and decrease
overall health care costs — not just get the right drug
to the right patient at the right time (although that will

always be important).

Absolutely, there are plenty of data to show that
pharmacists can save payers on the overall cost of
healthcare in both the short and long term. There

are hard data showing that within one year, simply
paying pharmacists to provide modest MTM services
for Medicaid patients delivered a 4 to 1 return on
investment. And data for the long term is even stronger
— an average ROI as high as 12 to 1.

Unfortunately, the way new federal bills are analyzed

doesn't account for these savings. The Congressional

If the case is so strong, what's keeping Congress?

That's a great question, but it
assumes that policy decisions are
always made with 100 percent
reliance on facts and data. The
reality is that national policy is
influenced by political pressures.
And one of the biggest political
pressures we're facing today is
our national debt and the ever
ballooning costs of entitlement
programs. Adding pharmacists’
services to Medicare benefits will
come at an added cost to the
program, at least initially.

So rather than reflecting on why it
hasn't happened yet, I like to focus
on why now is a good time. There
has never before been more of an
awareness on health policy in the
larger policy environment. Policy
makers are realizing that saving
money is more than simply cutting
costs — it’s also critical to get the
most value.

Pharmacists are pros at keeping
people healthy and maximizing
the utility of a critical healthcare
resource: medications. We have
plenty of data to show that.

More people are realizing this, so not only do we

have unprecedented collaboration among pharmacy
associations, wholesalers, and national pharmacy
chains, we are now seeing support from many outside
organizations such as the Centers for Disease Control

| challenge my peers not to
think of the current practice
environment. When we’re
talking about broadening
pharmacists’ services, think
of the future. Remember that
the reason we aren’t already
doing this is because our
payment system is broken — it
doesn’t recognize the value
pharmacists are capable of
providing. A core premise

of the provider status. push

is that we have to change

our business model. We

need to change the practice
environment and make it
feasible for our services to be
delivered effectively.

Budget Office assigns a “score” to bills that estimates the
cost of the bill to the federal budget over the next 10

years. But that score doesn't take
into account cost savings — which
doesnt help our cause one bit.
We've heard that this process may
be loosening a bit but the score of
the federal bill will continue to be a
challenge, especially in an election
year.

You've mentioned that Congress
would need to enact provider
status at the federal level. But
what about at the state level? Is
there any benefit to asking the
legislature to grant pharmacists
provider status on a state level?
What would state provider status
look like?

Absolutely, there is a lot states can
do to ensure patients access to and
coverage for pharmacists’ patient
care services (which is really what
we mean by “provider status,”
remember). Unfortunately, it isn't
as simple as a state legislature
granting provider status. The state
environment is different than the
federal one. At the federal level,

a somewhat simple change of

definition in law results in a massive change in the
payment structure for MANY patients across the country.
At the state level this almost always isn't the case.

There are often several places in state law and regulation
where the term “provider status” is defined, each with

and Prevention, the National Governors Association, the
Office of the Surgeon General, and others.

Okay, so Congress is concerned about the price tag. I

get that. Isn't there research, though, to demonstrate
that the long-term savings from compensating
pharmacists as providers is greater than the short-
term costs? I can imagine healthier patients and
reduced hospital admissions could save Medicaid and
Medicare some real money,

a different degree of impact on patient access to
pharmacists’ services. They may be important in their
own way but are very unlikely to be the broader solution
that a federal change would be.

Additionally, it’s at the state level where scope of practice
is defined, and that’s an essential factor in pharmacists’
ability to provide the care they want to provide. In recent
years, states have made improvements to laws regulating
pharmacists: broadening immunization and collaborative
practice agreements, allowing pharmacists to prescribe

MARYLANDPHARMACIST.ORG_ 13

travel medication, and promoting access to public health
services through pharmacies, such as smoking cessation
products and hormonal contraceptives.

Finally, states can influence local payers including
Medicaid, state employee plans, and private payers
through legislative or regulatory action, or by simply
working with those payers directly and sharing the
business case with them.

of practice? Providing services under collaborative
practice agreements with physicians? Or simply doing
stuff pharmacists can already do but currently can't
be compensated for?

All of the above. As we discussed before, state provider
status efforts often include work to align pharmacists’
scope of practice with their clinical ability — so patients
aren't missing out on pharmacists’ care because of
outdated laws. Collaborative practice agreements can
allow for increased collaboration and efficiencies in care
delivery — unless the state laws and regulations are so
restrictive that entering into an agreement becomes

a burden.

And finally there is “stuff” pharmacists can already

do and already are doing that they aren't being
compensated for. It won't be as easy as just submitting
a quick claim for services; we'll need to comply with
the rules and regulations other providers comply with
now — including credentialing, documentation, quality
assurance, etc.

How do you think physicians will react to that? Does it
change the physician—pharmacist relationship?

The examples we currently have of physician-
pharmacist collaborations are relatively few and far

between because it requires great creativity to make the
relationship financially viable. But when we are able to
find sustainable revenue streams to take the strain off of
the system, physicians often report favorably on working
closely with pharmacists. I think physicians and other
providers will embrace the presence of pharmacists

on the health care team. Let's face it — drugs are
complicated and there are plenty of other things doctors,
nurses, physician assistants, and nurse practitioners have
to focus on. Having a medication expert on their side
will make their job that much easier and allow them to
provide care to more patients.

How do you see this new paradigm impacting the
quality of patient care?

It's been said many times before, but I'll say it again:
When pharmacists are on the team, health outcomes
improve and costs go down. I think it’s a given that
pharmacists’ services can improve quality. The impact
pharmacists are already making, even in our broken
system, is probably underappreciated. But I think if

we align the incentives appropriately — and build an
infrastructure that allows pharmacists to access the
patient health data they need — the system can be fixed
to maximize pharmacists’ skills and improve patient care.

Let’s talk about compensation. If, as providers,
pharmacists could be compensated for a broader
range of their services, what does that look like? What
are the mechanics of it?

I dont want it to sound like an easy, quick transition.
We'll need to adjust workflows, reimagine how we use
pharmacy technicians, implement infrastructure changes
to allow pharmacists to plug into the information
systems hospitals and doctors use, and learn how to

do medical billing. And medical billing is VERY different

PROVIDER STATUS IN MARYLAND

Richard DeBenedetto, PharmD, MS, AAHIVP, Chair, Provider Status Working Group, Maryland Pharmacy Coalition

The need for pharmacists to be
recognized as providers to provide
services that improve outcomes

for patients is great. Pharmacists
being reimbursed for cognitive
patient care services, similar to how
other professions are reimbursed, is
necessary to place more pharmacists
into settings where they are
monitoring all aspects of medication
use. With small efforts to provide
MTM services, we see substantial ROI,
the expansion of MTM, disease state
management, and other cognitive
services. Expanded cost savings are

Medicare.

14 MARYLAND PHARMACIST | SPRING 2016

generated and value is placed on
pharmacist services where it belongs —
on the service and not on the product.

MARYLAND PHARMACY
COALITION (MPC) AND
PROVIDER STATUS

In the 2015 legislative session, MPC
developed and facilitated passage

of two bills signed in to law that
advance pharmacists as providers.
The first bill allows pharmacists to be
able to administer ‘self administered’
medications. While this sounds like

a minor effort, this is not allowed in
many states and improves our ability to
provide assistance to patients in need.
A second bill expanded the scope of
Drug Therapy Management Contracts,

While the federal provider status
initiatives are helpful in some respects,
they do not help all Maryland patients.
The federal law only would apply to
Medicare patients in underserved
areas; we have many Medicare patients
needing pharmacist services outside

of the specified areas and there are
many patients who are not covered by

It’s been said many times before, but Ill
say it again: When pharmacists
are on the team, health
outcomes improve and
costs go Gown. t think it’s a given

that pharmacists’ services can improve
quality. The impact pharmacists are already
making, even in our broken system, is
probably underappreciated. But | think

if we align the incentives appropriately

— and build an infrastructure that allows
pharmacists to access the patient health
data they need — the system can be fixed
to maximize pharmacists’ skills and improve
patient care.

than prescription billing, which is quick, automated and
immediately tells you if a claim is covered.

In medical billing, a claim is submitted, but the provider
may not know for weeks if it will be paid by the insurer.
Copays have to be collected at the time of service but
are only estimates of what the patient's cost share is

— meaning you have to bill the patient after the fact as
well. And if a claim isn't covered, the dispute process
can be lengthy and arduous. Obviously all of these
challenges have been overcome by our colleagues in
other health professions so they're not insurmountable,
but they will be big changes for pharmacy.

also known as collaborative practice
agreements. The changes allow for
pharmacists to initiate therapy under
protocol from physicians and also
allow non-physician prescribers

be contractually contained or legally
required in Maryland. We are also
looking to work with Medicaid and
other insurance providers to seek ways
to include pharmacists in the listing of

Sounds like this is an issue pharmacists need to
anticipate, so that when it’s enacted, our members
are ready to take advantage of it on day one.

What can pharmacists be doing now to prepare
themselves, their practices, and their patients for
provider status?

Pharmacists can get themselves ahead of the game by
incorporating services into their current business model
now. Start small. Consider incorporating medication
synchronization into your pharmacy. Incorporate other
adherence interventions. Make sure to fulfill all of the
Medicare Part D MTM opportunities that come your
way. This will help you to get your workflow to a better
place and start to change patient perceptions about the
level of care pharmacists are capable of providing.

Build relationships in the community. Reach out to
local physicians’ offices, get to know the care managers
in the local hospital and see if you can find a way to
help them with medication reconciliation at discharge.
Building relationships will also build a referral network.
Yes, this will mean business when we are able to bill
Medicare for medical services, but it will also mean
increased business now. If your local providers see

you as the go-to pharmacy for optimal medication
management, they will send their patients to you.

Try to understand the quality measurement landscape
— and beyond Star Ratings. Physicians, ACOs, medical
homes, and hospitals are all held to different quality
metrics. Learn what they are, learn what the pressure
points are, and think of how pharmacists can help to
achieve those metrics. Also, get to know the billing
codes that may be available to us through Medicare.
These include CPT codes, chronic care management
codes, G-Codes and more. The Medicare Learning
Network is a great resource. Sign up for their email list
and get information sent to you regularly. @

WHAT CAN YOU DO?

e Urge your elected leaders to
support HR 592/S314 Pharmacy
and Medically Underserved Areas
Enhancement Act

to enter into agreements with
pharmacists.

Our current efforts are now focused
on payment for pharmacist services.
We are currently allowed to do many
patient care activities, but have few
funding mechanisms for this care.
Through careful examination of
several insurance benefits contracts
and the law, we are researching areas
where expansion of payment may

providers who can bill for services.

Finally, we are working to change

the status quo by educating other
professions about the benefits of
pharmacists in the direct care of

their patients. Not only are there cost
benefits to the system for reducing
patient care expenditures, but other
providers can actually earn money by
including pharmacists who can bill
services on the patient care team.

Provide education to providers
on what pharmacists are qualified
and able to do for them and their
patients

Engage in formal opportunities
to collaborate in the professional
setting and improve professional
relations with other providers
outside the medical setting @

MARYLANDPHARMACIST.ORG 15

The Role of Ethics in Pharmacy

By: Dixie Leikach, RPh, MBA, FACA

President and CEO of PEER (Pharmacy Ethics, Education, and Resources)

Pharmacy is an honorable
profession. Pharmacists, student
pharmacists, and pharmacy
technicians work hard and spend
their days in stressful environments,
yet make a difference in patients’
lives. Pharmacy technicians are on
the front lines and are a pharmacists’
eyes and ears. Student pharmacists
study hard and dedicate the most
time of any healthcare professional
to the mastery of medications. While
this article focuses on pharmacists
and their role in making ethical
decisions, this topic is relevant to all
pharmacy professionals regardless
of role. Ultimately, running a
pharmacy is a team effort, and the
team must play by the same set of
rules to maximize efficiency and
effectiveness.

There are core assumptions that
those that decide on pharmacy as

a profession are knowledgeable,
educated, and ethical, and that these
individuals want what is best for the
patient at all times. Ethics plays a
large part in the public's perception
of pharmacists and patient safety.
However, little information on
pharmacy-specific ethics exists,

and few educational sessions are
available to improve pharmacist's
knowledge. The more discussions
pharmacists have on ethics, the
better pharmacists can serve their
patients.

Autonomy, beneficence,
nonmaleficence, and justice are

the four leading healthcare ethical
principles.* Autonomy is the principle
that patients have the right to make
their healthcare decisions, and the
job of the healthcare professional

is to ensure the patient has all of
the necessary information to make
their decisions. The healthcare
professional must respect the
decision of the patient, even if

the decision doesn't perceive the
patient's best interest. Beneficence
is the principle that healthcare
professionals must strive to do the
best for every patient in every unique
situation. Nonmaleficence is the
principle of “first, do no harm” and
is the principle that most healthcare
professionals recognize and follow.®
The last principle, justice, highlights
that healthcare professionals

must be fair and consistent in
treatment decisions and allocations
of resources for every patient. In
making a sound ethical decision of
justice, healthcare professionals must
be able to justify their actions.*

Although pharmacy is a healthcare
profession, in many practice settings,
it is also a business. Therefore, the
principles of business ethics must
also be considered. Healthcare is
changing and payment models are
shifting. Pharmacists must comply
with both business and healthcare
ethical principles when making
decisions in their workplace in order
to keep the patient's best interests

at the forefront. Many principles

are considered business ethics,

but there are common themes
among all such as, trustworthiness,
responsibility, citizenship, fairness,
caring, and respect. Integrating all of
these principles into each decision
can be difficult, but one easy way to
determine if a business decision is
ethical is by considering whether it
would hold up under the scrutiny of
a regulatory review or audit.

16 MARYLAND PHARMACIST | SPRING 2016

Thorough knowledge and
consideration of pharmacy
regulations is a prerequisite to
making sound decisions. This

is necessary not only because
adherence is mandated, but also
because many of the regulations
resulted from high-profile

situations where the actions of

a few pharmacists purposefully

or accidentally ignoring sound
ethics resulted in significant patient
harm and great public concern.
Consequently, laws were then
changed to prevent a recurrence.
Two cases in particular have had
lasting effects on our profession, and
it is important for all members of the
pharmacy team to reflect on them.

One particular law that dictates
most of the pharmacy profession
today is the Federal Food, Drug,

and Cosmetic Act of 1938.4 This law
was the result of the sulfanilamide
tragedy, and with its many updates
it still stands today. The pharmacist
that concocted the poisonous
substance containing diethylene
glycol, an antifreeze agent, to hide
the flavor of the bitter medication
may or may not have known that
there was a risk with the formula
used. Whether the pharmacist knew
beforehand this was a potent poison
was never determined, but regardless
of his knowledge, ultimately over
100 people died and countless
more sustained serious illness. As
healthcare professionals, the need
to embrace change and look for
new ways of healing are necessary.
However, healthcare professionals
always need to consider the worst
Case scenario and make sure the
mainstay principle of ethics is being

honored: nonmaleficence, first do
no harm.

are not always easy and sometimes
contradict each other. However, it
is crucial to continue to increase
awareness and education on the
topic of ethics and how it plays an
important role in pharmacy in order
to better serve patients. @

patient harm and a tremendous
change in the profession. As seen in
both examples, the breach of ethics

More recently, the Drug Quality and
can irrevocably change lives.

Security Act of 2013 is the result of
the New England Compounding
Center tragedy, where one pharmacy
caused 64 deaths and illness in over
800 patients due to poor practice
and alleged illegal activity.° Violations

Ethics plays a large role in healthcare
professionals’ everyday lives.
Pharmacists that consider ethics in
their daily practice are more likely

to improve patient safety and their

of many ethical principles caused

References:

standard of practice. Ethical decisions

1. Buerki RA, Vottero LD. Pharmacy Ethics: A Foundation for Professional Practice. Washington, DC: American Pharmacists Association; 2013.
2. Runzheimer J, Larsen LJ. Basic Principles of Medical Ethics. Dummies Website. http://www.dummies.com/how-to/content/basic-principles-of-medical-ethics.html.

Accessed September 10, 2015.

3. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 2nd ed. New York, NY: Oxford University Press; 2013.

4. Martin Barbara J. Elixir: The American Tragedy of a Deadly Drug. Lancaster, PA: Barkerry Press; 2014.

5. Kennan Stephanie A. Drug Quality and Security Act What You Need to Know. McGuireWoods Website. https://www.mcgutrewoods.conv/Client-Resources/
Alerts/2013/12/Drug-Quality-and-Security-Act.aspx. Updated December 4, 2013. Accessed September 10, 2015.

University of Maryland School of Pharmacy

Celebrates 175th Anniversary continued from page 11

“All alumni should be proud to be part of the School's
amazing 175-year legacy,” says Sharon Park, PharmD
‘04, president of the School's Alumni Association. “It is
important to remember, however, that it is not only the
number that is important, but also the excellence and
dedication of the School's faculty, staff, students, and
alumni that has persevered over all this time.”

A Grand Birthday Celebration

To formally kick-off the School's year-long anniversary
celebration, Natalie D. Eddington, PhD, FCP, FAAPS,
dean and professor of the School, hosted a birthday
celebration for faculty, staff, students, and alumni on
Feb. 10. The celebration, which featured birthday cakes
decorated with photos of the five different buildings

in which the School has been housed throughout the
years, offered an opportunity to reflect on the School's
history and called on attendees to look beyond the
School to how the advances being achieved within its
walls could make the greatest impact on the

local community.

“The one word that comes to mind when | think

about the School on the occasion of its 175th
anniversary is community,” says Eddington. “We are a
strong, thriving community of scholars, practitioners,
researchers, students, and staff. As we kick off the many
celebrations that will mark this milestone year, my
challenge to all of you is to think about the community
beyond the walls of Pharmacy Hall. I want all of us to
work together to focus on service during this 175th
anniversary, and to build upon the great work that

our faculty, staff, and students already do with many
community groups.”

Beyond the Wails of

Pharmacy Hall

From offering tutoring services for middle and high
school students to conducting research that leads to
the development of new medications, there is a lot of
great work being done by faculty and students alike

to help enhance the local community. Faculty in the
School's Department of Pharmacy Practice and Science
partner with more than 200 community pharmacies,
hospitals, nursing homes, and other agencies to
provide services to residents and practitioners across
the state of Maryland and beyond. The Patient-
Centered Involvement in Evaluating the Effectiveness
of Treatments (PATIENTS) program led by C. Daniel
Mullins, PhD, professor and chair of the Department of
Pharmaceutical Health Services Research at the School,
has also been recognized for its groundbreaking work
to empower patients to propose questions about their
health care and participate in research studies designed
to help answer those questions.

However, as Eddington notes, there is still much work to
be done.

“Baltimore City is much different today than it was

in 1841," adds Eddington. “It is a vibrant, dynamic
community, but it is also in need of our assistance. Many
of our neighbors lack access to basic goods and services,
as well as to health care. Faculty, staff, students, and
alumni at the School have a multitude of expertise and
the ability to help move our city forward. We have the
manpower, the drive, and the heart to be more involved
and to make more of a difference.” @

MARYLANDPHARMACIST.ORG 17

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Continuing Ed

Take Each Pill with a
Grain of Salt:

A Review of Abuse-Deterrent Opioid
Formulations and Place in Therapy

Diana Stewart, Pharm.D., PGY2 Pain and Palliative Care Resident

Mary Lynn McPherson, Pharm.D., MA, BCPS, CPE;
Professor and Executive Director Advanced Post-Graduate Education in Palliative Care

University of Maryland School of Pharmacy

Opioids have been used for their analgesic and sedative properties throughout history; references to
medical use of the opium poppy plant can be found dating back to ancient civilizations in Mesopotamia as
early as 3000 B.C.! With the therapeutic use of opium came struggles with abuse and addiction, prompting
the search for safer analgesic agents. Morphine (named for Morpheus, the god of dreams) was isolated in
1806, but was quickly found to have a similar potential for abuse as opium. When heroin was synthesized
almost a century later, it was initially touted as a potent analgesic and abuse-free opioid.“ Needless to say,
such claims of low potential for abuse and addiction from morphine and heroin have been thoroughly
discredited.

Despite significant advancements in drug development in other therapeutic areas, opioids remain the gold
standard for treatment of severe acute and cancer-related pain. The use of opioids for chronic non-cancer
pain is more controversial. It is estimated that 90-95% of prescriptions for long-term opioid therapy are
for non-cancer indications.’ Opioid prescribing increased significantly since the early 1990s when quality
initiatives, such as ‘Pain as the 5th Vital Sign’ through the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) and the Veterans Health Administration sought to address inadequately treated
pain through the promotion of consistent standards for monitoring and treating pain.* Unfortunately,
increases in opioid prescribing are mirrored in trends in abuse and overdose deaths and have led to an
opioid epidemic in the United States.

Learning Objectives
After completing this activity the participant will be able to: Key Words
1. Describe trends in opioid abuse and overdose in the United States. * Abuse deterrence

2. List the seven types of abuse-deterrent formulations as defined by * Opioids
the FDA.

3. Describe the abuse-deterrent properties of commercially available
products according to the FDA guidance.

e Drug formulation

e Pain management

4.Select an appropriate candidate for treatment with an abuse-
deterrent opioid formulation within a patient case study.

MARYLANDPHARMACIST.ORG 19

The Opioid Epidemic

The sale of prescription analgesics has quadrupled in
the United States since 1999. Likewise, the incidence of
opioid-related overdose deaths has quadrupled in the
same time frame, and more than sixty percent of drug
overdose deaths involve an opioid.’ The agents most
commonly implicated in prescription opioid overdose
deaths are methadone, oxycodone, and hydrocodone.®
It should be noted that 73 to 80 percent of methadone
overdoses have been classified as unintentional, and
the absolute number of overdose deaths involving
methadone was less than those involving cocaine,
oxycodone, hydrocodone, and fentanyl.’

The rate of heroin abuse has also increased substantially
since 2006, and the rate of related overdose deaths

has more than tripled since 2010.° Heroin use is
increasing in populations with historically low rates of
abuse including women, the privately insured, and those
with higher incomes. Prescription medications may

be perceived as safer than illicit substances, however
addiction to opioid analgesics has been cited as the
strongest risk factor for heroin addiction. Individuals
who are addicted to opioids are forty times more likely
to be addicted to heroin compared to fifteen times
more likely if addicted to cocaine, and three times more
likely if addicted to marijuana.?"° While inadequately
treated pain was a concern in the early 1990s, the
inextricable relationship between prescription opioids,
and prescription and non-prescription opioid abuse,
addiction, and overdose deaths is a national priority and
has led to the recent implementation of initiatives at
local, state, and federal levels.®

Sidebar Case

Combating Opioid Abuse

Many strategies aim to reduce access to opioids for
illegitimate or non-medical uses. These include state
prescription drug monitoring programs, educational
programs for healthcare professionals and the public,
overdose prevention measures with opioid antagonists
such as naloxone, and punitive legislation.°' These
tactics do not alter the abuse potential of opioids, and
critics have voiced concern that stringent regulation of
prescribing practices may limit access to appropriate
therapy for patients with legitimate pain. Abuse-
deterrent formulations are a newer tactic employed

by drug manufacturers to make the dosage form
difficult to manipulate for non-medical purposes. This
is differentiated from tamper-resistance, which typically
refers to packaging requirements for a medication.

The most common route of administration implicated
in opioid abuse is oral ingestion of an intact or
compromised dosage form, but can also involve
inhalation or injection. Dosage forms can be crushed,
chewed, ground, pulverized or extracted to make the
medication easier to swallow or allow for an unintended
route of administration. Physical alteration decreases the
time to maximum concentration (Tmax) and increases
the maximum concentration (C3) achieved to enhance
euphoric effects of the opioid. Many of the commercially
available abuse-deterrent opioids make physical
alteration difficult and thwart this dose-dumping effect.
The U.S. Food and Drug Administration (FDA) released

a draft guidance report for pharmaceutical industry

on abuse-deterrent opioids in 2013 and final guidance
in 2015. The intent of the guidance is to facilitate the
development of safer, abuse-deterrent products by
providing non-binding standards for abuse-deterrence
studies, product formulations, evaluation, and labeling.

Prescribing Considerations for Abuse-Deterrent Opioids |

Henry, a 35 year-old man, was referred to a pain clinic for chronic lower back pain secondary to a motor vehicle accident.
Henry's primary care physician referred him to the clinic after multiple early refill requests for opioids. His current analgesic
regimen consists of acetaminophen 650 mg by mouth every 4 hours as needed, MS Contin® (morphine extended release) 15 mg
by mouth every 8 hours, and oxycodone 5 mg by mouth every 4 hours as needed. He did not complete recommended physical
therapy because he said “it didn’t do any stinking good" and high co-pays. Henry is an active smoker (1 pack per day) and has

a remote history of cocaine use ten years prior. The patient is 5'10" and weighs 280 pounds; when asked he says ‘I'm a couch
potato and proud of it." When asked about his goals for the treatment plan, Henry states that he would like to increase the dose
of his MS Contin® and breakthrough oxycodone so as to be able to return to his job as an accountant and play with his two
young children. He is concerned about switching to one of those “new, fancy drugs” due to high costs.

Is this patient at risk for

opioid abuse?

Patients should be screened for risk of
opioid abusive drug-related behaviors
using a validated tool during initial

20 MARYLAND PHARMACIST | SPRING 2016

assessment. Risk factors that have been
determined to be clinically significant
include a family or personal history of
substance abuse with alcohol, illegal
drugs, or prescription drugs, age

between 16 to 45 years, history of pre-
adolescent sexual abuse, concurrent
psychological disease, and male
gender.“ Henry has multiple “red flags”
— he did not follow the complete plan

Potential formulations of abuse-deterrent opioids have
been broadly defined within seven categories and are
summarized in Table 1.*°

In order to meet the labeling requirements set forth

in the guidance, a medication must demonstrate
safety and efficacy in pre- and post-market studies.
Category 1 studies evaluate in vitro manipulation and
extraction to assess the ease with which the abuse-
deterrent properties can be defeated or compromised.
Category 2 studies compare the pharmacokinetic
profile of manipulated and intact formulations against
comparator formulations through one or more route
of administration. Category 3 studies are referred to as
drug-liking studies and evaluate how probable it is that
the formulation will be attractive to abusers. Category
4 post-market studies determine if the formulation
resulted in a meaningful reduction in abuse, misuse,
addiction, overdose, and death.’* Studies should

assess known or anticipated routes of abuse that are
specific to that opioid. By limiting one form of abuse,

it is critical that the product does not encourage an
alternative, potentially more dangerous route of abuse,
such as intravenous injection of an opioid following
reformulation to prevent crushing and snorting. Many
of the abuse-deterrent products currently on the market
target multiple potential routes of administration for
this reason.

Abuse Deterrent Opioids

Three products have received FDA approval for abuse-
deterrent labeling in the United States. Oxycodone is
an opioid that has been widely abused, particularly the
extended release formulation OxyContin®. This was the
first opioid to be reformulated with abuse-deterrent
properties in 2010 and received FDA approval for

abuse-deterrent labeling in 2013. OxyContin® utilizes
proprietary INTAC® technology that is resistant to
crushing, breaking, and dissolution and is categorized as
a physical/chemical barrier. If submerged in an aqueous
environment, the tablet forms a viscous hydrogel that
resists passage through a needle and cannot easily

be snorted. Early category 4 post-marketing studies
demonstrated a 32-33 percent reduction in abuse, a

15 percent reduction in overdoses, and a 22 percent
reduction in street price.**°

Hysingla®, extended release hydrocodone, received
approval for abuse-deterrent labeling in 2014 and is
classified as a physical/chemical barrier. This agent
utilizes a proprietary RESITEC® formulation that confers
tablet hardness to resist crushing or chewing, and forms
a viscous substance if dissolved in aqueous solutions to
deter snorting or injecting.”

Embeda® is an agonist/antagonist formulation that
was approved in 2014. It contains a combination of
extended release morphine and the opioid antagonist
naltrexone, which is sequestered and has no effect if
taken as directed. The naltrexone is fully released if
the dosage form is crushed, chewed, or dissolved in

a solvent and may precipitate withdrawal in opioid-
dependent patients.”

Other commercially available opioids have physical/
chemical barriers against abuse, but have not received
FDA approval for abuse-deterrent labeling. Zohydro®

is extended release hydrocodone formulated with
BeadTek®, an excipient that inmediately forms a viscous
gel if the tablet is crushed and dissolved to deter snorting
or injecting.18 Exalgo® is an extended release product
containing hydromorphone. Exalgo® is formulated with
an osmotic delivery system that is resistant to crushing -
and extraction, and releases the hydromorphone at a

of care (physical therapy), history of
smoking and cocaine use, and multiple
requests for early refills.

What observed behaviors might
be of concern for opioid abuse

or misuse?

Aberrant behavior describes patient
actions that are inconsistent with

the prescribed treatment plan. These
range from mild behaviors, such as
using pain medication to treat other
symptoms such as anxiety, to more
severe behaviors such as crushing
and snorting oral medications to
achieve more rapid onset. Drug-
seeking behavior is often a red flag to
prescribers, but behaviors may overlap
with signs of untreated pain: frequent
emergency room visits, preoccupation

with obtaining pain relief, and
requesting specific analgesics by
name.” Henry's physician states the
patient is consistently requesting early
refills of opioids.

What factors should be considered
prior to recommending an abuse-
deterrent opioid?

First, determine if the patient is an
appropriate candidate for opioid

analgesia based on the pain syndrome.

For example, low back pain is a
chronic condition where opioids are
usually NOT recommended. Henry
should follow the plan of care for drug
and non-drug therapy, and life style
modification is likely an important
part of his treatment plan (lose weight,
exercise). Also, neuropathic pain is

generally a considerable part of low
back pain; Henry would likely benefit
from an adjunctive analgesic such

as gabapentin, pregabalin, a tricyclic
antidepressants, or duloxetine.

Assuming opioid therapy is
appropriate, it is important to obtain
a thorough history and conduct a
validated risk assessment to identify
patients who are actively abusing

or at high risk for abusing opioids,
and by what route. Other factors to
consider include insurance formularies
and the patient's ability to afford the
medication, if the abuse-deterrent
formulation targets anticipated routes
of abuse, and if the patient is able to
ingest the intact dosage form.

MARYLANDPHARMACIST.ORG 21

controlled rate over 24 hours.’? New abuse-deterrent
opioids are currently under development, some of which
feature aversion technology with substances like niacin
that would cause nasal irritation and flushing if the tablet
were crushed and snorted.

Conclusion

The number of abuse-deterrent opioids that have
been brought to market in recent years is reflective of
a collective commitment to addressing the national
opioid epidemic. Despite this, place in therapy for
these products remains unclear due to several factors.
The rate of opioid-related deaths has continued to
increase despite the introduction of abuse-deterrent
formulations.*° A study of 11,000 drug users at 150
treatment centers across the U.S. revealed that 25
percent continued to abuse OxyContin® even though
they found the new abuse-deterrent formulation to
be less attractive.*! Perhaps a more sobering trend is
an increase in heroin abuse by almost 100 percent
which has coincided with a 474 percent reduction

in OxyContin® abuse. This is largely due to reduced
availability of the old OxyContin® formulation that lacked
barriers to abuse, and a lower relative cost of heroin

Regulations and medication-based technology must

be capable of evolving with rapidly changing trends

to continue to provide a meaningful impact in abuse.
Users who are determined to obtain euphoric effects can
easily find tips and how-to videos on web-based forums
with detailed instructions on defeating abuse-deterrent
properties. Although the new formulations prevent
alteration of the dosage form, they do not prohibit
patients from ingesting a higher quantity than directed
to achieve desired effects and do not protect against the
most common form of ingestion in opioid overdoses —
the oral route.

Most importantly, reformulating opioids to reduce abuse
does not address underlying issues with addiction or
prevent patients from becoming addicted. The abuse-
deterrent formulations may be beneficial in a subset

of patients; particularly those identified as high risk for
abuse based.on validated screening tools. Patients who
abuse opioids by inhalation or injection may also be
appropriate candidates for abuse-deterrent formulations,
but must be monitored closely to ensure they are not
shifting to heroin abuse. Patients may even request
these products if they are concerned about diversion

in the home from family, friends, or caregivers. Crush-

compared to OxyContin®.~ Cost is a limiting factor for
many patients, as generic products are more favorably
priced and the abuse-deterrent products are currently
brand-only. Coverage for OxyContin® under Medicare
Part D actually decreased from 61 percent to 33 percent
from 2012 to 2015 while the generic immediate-release
formulation of oxycodone, which lacks abuse-deterrent
properties, was fully covered.* Price competition may
reduce prices as more abuse-deterrent formulations are
approved however high co-pays are a barrier for many

resistant opioids are not appropriate for all patients,
particularly those with enteral feeding tubes. It is
imperative that healthcare providers remain aware of
the distinction between abuse-deterrence and abuse-
proof to avoid developing a false sense of security. The
prescribing of abuse-deterrent formulations does not
preclude completing initial and repeat risk assessments,
performing appropriate monitoring and follow-up, or
using good clinical judgment. Opioid abuse is a complex
and deep-rooted problem that requires a multimodal

patients. approach in order to affect meaningful change.

References

1. Teall EK. Medicine and doctoring in ancient 10. Compton WM, Jones CM, Baldwin GT. 17, Embeda?® [package insert]. New York, NY: Pfizer
Mesopotamia. Grand Valley Journal of History Relationship between nonmedical prescription- Inc.; 2014.

2014 S(i alee: opioid use and heroin use. N Engl J Med 18. Zohydro® [package insert]. Morristown, NJ: Pemix

2. Brownstein MJ. A brief history of opiates, opioid 2016;374:154-163. Therapeutics, LLC.; 2016.
peptides, and opioid receptors. Proc NatlAcad Sci 11. Webster LR. Ending unnecessary opioid- 19. Exalgo® [package insert]. Hazelwood, MO:
1993;90:5391-5393. related deaths: a national priority. Pain Med Mallinelcodt Brae Crariace tical bier

3. Sullivan M, Ferrell B. Ethical challenges in the 2011;12:S13-S15. 20. Leece p, Orkin AM, Kahan M Taneenteaeone
management of chronic nonmalignant pain: 12. U.S. Food and Drug Administration Center for ; drugs ceneaeenetha opioid crisis. CMAJ 2015:
Negotiating through the cloud of doubt. J Pain Drug Evaluation and Research. Abuse-deterrent DOI:10.1503/cmaj.150329
2005;6:2-9. opioids — evaluation and labeling guidance for 1G TJ, Ellis MS. A :

4. Pletcher Md, Kertesz SG, Kohn MA, et al. Trends in industry. Silver Spring, MD 2015. puget pa isa pale mld hs.
opioid prescribing by race/ethnicity for patients 13. Harris SC, Perrino PJ, Smith I, et al. Abuse United ere pete Payenan aol Toes:
seeking care in US emergency departments. potential, pharmacokinetics, pharmacodynamics, 430
JAMA 2008;299(1):70-78. and safety of intranasally administered crushed an F

5. Centers for Disease Control and Prevention. oxycodone HCl abuse-deterrent controlled- Es ee Leas fier pe oe ee
Increases in drug and opioid overdose deaths — release tablets in recreational opioid users. J Clin a One en OF Ore ONT SIDE Nes a
United States. 2000-2014. MMWR 2015;64:1-5. Pharmacol 2014;54(4):468-477. . RNIN oe

6. Ossiander EM. Using textual cause-of-death 14. Severtson SG, Bartelson BB, Davis JM, et al. es Mages ae eo au Pee
data to study drug poisoning. Am J Epidemiol Reduced abuse, therapeutic errors, and diversion chalieto ae a ave Ankh ie gkes k
2014:179(7):884-894. following reformulation of extended-release properies: Weshiigeory =.

oe oxycodone in 2010. J Pain 2013;14(10):1122-1130. 24. Webster LR, Webster RM. Predicting aberrant

7. Kung HC, Hoyert DL, Xu JQ, et al. Deaths: Final behaviors in opioid-treated patients: limi
data for 2005. National vital statistics report 15. Butler SF, Cassidy TA, Chilcoat H, et al. Abuse idanowiad tee cee cae en
2008:56(10):1-124. rates and routes of administration of reformulated peewee vies a pase rer eee ee

8 ; f extended-release oxycodone: initial findings d i : : |
Dart RC, Surratt HL, Cicero TJ, et al. Trends in from a sentinel surveillance sample of individuals 25. Larance B, Degenhardt L, Lintzeris N, et al.
opioid analgesic abuse and mortality in the F initi i
United States. N Engl J Med 2015:372-241-248 assessed for substance abuse treatment. J Pain Definitions related to the use of pharmaceutical

ee is g net ; 2013;14(4):351-358. opioids: extramedical use, diversion, non-

enters for Disease Control and Prevention. Vital 16. Hysingla® [package insert]. Stamford, CT: Purdue adherence, and aberrant medication-related

signs: Today's heroin epidemic — more people at
risk, multiple drugs abused. MMWR 2015.

Pharma L.P.; 2014.

22 MARYLAND PHARMACIST | SPRING 2016

behaviors. Drug Alcohol Rev 2011;30:236-245.

Table: Abuse-Deterrent Formulations (12)

FORMULATION DESCRIPTION EXAMPLES

Physical/ chemical barriers | Drug release limited following e Physical barriers prevent chewing,
manipulation, or physical form is changed crushing, cutting, grating, or grinding
to make it more difficult to abuse

e Chemical barriers resist opioid
extraction with water, alcohol, or
organic solvents

Agonist/ antagonist Interfere with, reduce, or defeat euphoria ¢ Opioid antagonist, such as naloxone,
combinations associated with abuse may be sequestered so that it is only
released upon product manipulation

e Irritation to nasal mucosa if
manipulated product were snorted

Aversion Substance added to opioid to produce
unpleasant effects if the dosage form is
manipulated or used at a higher dose

than directed

Delivery system Drug-release designs or delivery methods e« Depot injections and implants that are
that offer resistance to abuse difficult to manipulate

New molecular entities Could contain a chemical barrier to in vitro | « Need for enzymatic activation
and pro-drugs conversion to active opioid to deter abuse

¢ Different receptor binding profiles

e Slower penetration into the central
nervous system

e Other novel effects

Combination Two or more formulations combined to e Combination of physical barrier
deter abuse and aversion

Novel approaches Novel approaches or technologies not
captured in previous categories

CONTINUING EDUCATION QUIZ

PharmCon is accredited by The authors have no financial disclosures
ae Ba cd pone eno (2) Scroll down to Homestudy/
ot aeee peal oe This program is Knowledge Based — OnDemand CE Credits and select the
® Sees en ee acquiring factual knowledge that is based Quiz you want to take.
r
: d ccepted in the literature .
continuing education credit ae oe Tash ve oeedl eters eines (3) Log in using your username (your
will be awarded within six to eight weeks. y email address) and Password
Directions for taking this issue’s quiz: MPHA123 (case sensitive). Please

Program Release Date: 05/01/16 change your password after logging

This issue's quiz on Take Each Pill with
in to protect your privacy.

Program Expiration Date: 05/01/19 a Grain of Salt: A Renew of Abuse-

This program provides for 1.0 contact Deterrent Opiod Formulations and (4) Click the Test link to take the quiz.

hour (0.1) of continuing education Place in Therapy can be found online Note: If this is not the first time you are

credit. Universal Activity Number (UAN) at www.PharmCon.com. signing in, just scroll down to Homestudy/

ee eed (1) Click on “Obtain Your Statement of OnDemand CE Credits and select the quiz
CE Credits for the first time. you want to take.

CE Questions Answers from page 24
4)-B:.2) C;.3) A; 4) D;'5) B; 6) A; 7) D; 8) C; 9) B; 10) A

MARYLANDPHARMACIST.ORG 23

CE Questions

1 Physical barriers against opioid abuse are best 6 The incidence of OxyContin® abuse has decreased
described as: substantially since the product was reformulated
in 2010. What other trend has coincided with this

A. Medication formulations that prevent oral
change?

ingestions

B. Medication formulations that prevent chewing, A. Increase in heroin use

crushing, or grinding . Increase in insurance coverage for OxyContin®

C. Chemicals that inactivate the opioid if the product . Decrease in heroin use

is manipulated Decrease in the use of other opioids

D. Medication formulations that inhibit addictive

properties of opioids a
7 Which opioids use physical/chemical barriers to

prevent abuse?
What category of abuse-deterrent formulation studies A
evaluates how probable it is that the formulation will
be attractive to abusers in drug liking studies B. Exalgo

A. Category 1 C. Embeda

B. Category 2 D. AandB
C. Category 3 E.All of the above
D

OxyContin

Category 4
8 The most common route of administration involved in

eek opioid overdoses:
Which of the following was the first opioid to receive

FDA approval for abuse-deterrent labeling? A. Inhalation
A. OxyContin® Injection

B
Vicodin® Cam Oral
D. Rectal

B
C. Hysingla®
D. Exalgo®

9 Which of the following is a barrier to the utilization of

“4 abuse-deterrent opioid formulations?
4 The sale of prescription opioids has almost :

quadrupled in the last decade, while the incidence of A. Lack of guidance from regulatory bodies
has quadrupled as well. High cost associated with branded products

B
Opioid-induced constipation C. Lack of prescriber awareness of opioid abuse
D

Marijuana abuse No opioids have been approved with abuse-

Reported pain by patients deterrent labeling

Opioid-related overdose deaths

10 Prescribing abuse-deterrent opioids for patients with
pain would be most appropriate based on which of

5 Embeda® (extended release morphine/naltrexone) the following characteristics?

utilizes which type of abuse-deterrent formulation?

A. Patients who report crushing and snorting opioids
A. Physicalichemical barrier to achieve faster onset of analgesia

Agonist/antagonist combination B. Patients with young children in the home

Patients with multiple emergency department

B
C. Aversion technology
D. Delivery system visits for back pain

Patients who require medications be crushed for
administration through a PEG tube

Answers on page 23

24 MARYLAND PHARMACIST | SPRING 2016

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your practice site. There
are numerous short-term
projects and longer-term
leadership opportunities that need your diversity of thought,
practice specialty, and experience to make them a success.
Many new initiatives come from suggestions made by
individual members like you.

The first quarter of 2016 has been quite busy for MPhA!

ADVOCACY

MPhA didn't introduce legislation this year, but we had an
engaged legislative session, much of the work involved
providing feedback on policy, legislative, and regulatory issues.
Thank you to the Advocacy Committee, for providing timely
feedback and comments during the session. We made strides
in distinguishing MPhA from many other pharmacy interests
by providing oral and written testimony; participating in
committee working groups; and using our lobbyist to provide
follow-up information; and having one-on-one meetings

with Delegates.

MPhA connected with the Maryland Congressional Delegation
in Washington, DC to educate them about MPhA and to
encourage more support of provider status legislation. It was
great fun to the attend the APhAPAC reception in Baltimore,
which featured Congressman Elijah E. Cummings. He is an
advocate for the profession and has a powerful story to tell
about his connection to the Maryland pharmacy community.

What's Next?: More meetings with Maryland Congressional
delegation. Preparation for the 2017 General Assembly —
meetings are already scheduled with General Assembly
leadership, Delegates and members of Hogan's administration.

COMMUNICATIONS ¢ OUTREACH

Maryland pharmacists strive to be innovative and respected
members of the healthcare team. Part of that effort means
we must share with the broader public the great things we
are doing. Please continue to share that information with
MPhA staff. We have set up a communications model to get
press and media communications out quicker. Thank you to
the Communications Committee for initiating the Facebook
“Likes Campaign,” streamlined our social media hashtags,
and have other efforts underway to assist with giving the
MPhA brand more staying power. Outreach means more

Executive Director’s Message

targeted connections with prospective members. Kudos to the
Membership Committee for developing and welcoming the
Federal Pharmacist Network.

What's Next? MPhA Trivia Week; Member Spotlights; and
Pharmacist technician programming.

CONTINUING EDUCATION ¢ NETWORKING

There were many activities that provided CE credits, but also
gave time for you to meet and connect with old colleagues
and build new relationships. In the first quarter, Hoai-An and

I traveled to the Eastern Shore, Mid-state, and we are looking
forward to visiting our Western Maryland friends at the end of
this month. Thank you to the Meeting Planning Committee and
others who have facilitated increased CE content for the Mid-
Year and Annual Convention. Thank you to the NPN Network
for continuing to provide engaging activities that keep new
practitioners connected to MPhA. Thank you to our University
Partners — APhA’s Maryland Pharmacy Night Reception had
record attendance and was enjoyed by all!

What's Next?: New Practitioner Network Activities for recent
graduates focused on transitioning from student to practicing
professional and a new on-staff CE Coordinator.

PROFESSIONAL DEVELOPMENT ¢ PROFESSIONAL
RECOGNITION

We have a new Pharmacist Advocate Award, sponsored by
Buy-Sell-A-Pharmacy, which recognizes the government affairs
activity that has raised pharmacists’ awareness of the political
process, improved the pharmacy profession and the political
process, and/or improved service and education to the patient.
The award will be presented at the June Convention.

What's Next?: A medication synchronization and adherence
panel discussion bringing together national leaders and
Maryland innovators under the ScriptYourFuture Maryland
(SYFM) banner. We will also see the launch of a CRISP Portal
Accessibility Pilot for Pharmacists. There will also be roll-
out of Provider Outreach materials from the Professional
Development Committee.

Thank you again to the many MPhA volunteers and to your
support network. Your time and commitment is appreciated!

If | don't see you beforehand, I'll see you in the OC! @

Aliyah N. Horton, CAE
Executive Director

MARYLANDPHARMACIST.ORG 27

Do you know a pharmacy technician
ready to take on more responsibility
in the pharmacy?

The University of Maryland School of Pharmacy’s new, online PharmTechX
Program will elevate a technician’s abilities and improve the efficiency of
your pharmacy.

The PharmTechX Program at At the end of the program, technicians will be able to:
the University of Maryland ¢ Assist with medication management and storage
School of Pharmacy offers ¢ Conduct medication profile reviews

an online, self-paced, ¢ Assist with patients’ medication histories

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advance a technician’s skills
and education.

¢ Complete medication checking
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¢ Facilitate improvement of the medication process

UNIVERSITY of MARYLAND
SCHOOL OF PHARMACY

™~

134" Annual Convention

The Opening Session Speaker
at the 134" Annual Convention
presented on Keeping Cool,
Calm & Collected when the
Pressure is On.

SUMMER 2016

EXCELLENCE IN
PHARMACY
AWARDS

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PHARMACY CREDENTIALING ASSESSMENT
vesno @& FWA sno @ PHARMACY OPERATIONS

Are staff members trained on CMS 10147

Adherence if a “569 error” occurs?

Do you have Policies and Procedures (P&P) to meet
Interest forms annually? Pharmacy Medicare Part D credentialing

Are you running OIG-GSA-SAM Exclusion Verifications each month on: requirements?

Are you conducting FWA Prevention training annually?
Do you have an “Anti-Kickback” Policy & Procedure (P&P)?
Do you have your entire staff completing Conflict of

Employees, Owners and Contractors Are you keeping annual records of all trainings
Business Associates (HIPAA & FWA with 10 years of retention)?
All vendors whose products are billed through Medicare Do you review your EQuiPP scores monthly?
Do you have a Medication Adherence Program?
YES HIPAA

Do you have P&P’s for:
Do you have a HIPAA P&P manual/program in place?
Has your Notice of Privacy Practice been updated since
July 1, 2013?
Do you maintain a breach assessment when the patient
receives another patient’s medication?

YES PATIENT SAFETY

Do you have a Quality Assurance Program?
Are you enrolled in a Patient Safety Organization?

Usual and Customary

Patient Counseling Practices
Mis-fill Procedures

Medication Recall Procedures
Medication Expiration Procedures
Generic/Brand Price Disclosures
Demographics and Allergy Capture
Partial Refills

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We’re here to keep you

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Contents a eh We

10 VA :
COVER STORY =, Aneta |

134" Annual Convention Updates my, NY 4 ees
wn Annual Convens;
Follow-up to Martha Bryan's presentation on Keeping Cool, Calm & bys A ae)

Collected when the Pressure is On. Awards and recognitions. Thank
you to all our supporters and contributors who assisted in making / i
the 134" Annual Convention a success. ee é

, 5 ©
: rt v

4
President’s Pad

MPhA News

6 | Congratulations

6 | Maryland Appointees to APhA 2016-2017
House of Delegates

6 | Medical Mission Trip to Haiti

6 | Pharmacy School Highlights

15 | Welcome 2016-2017 MPhA Board of Trustees

22 | Welcome New Members

23 | Save the Dates

Editorial

5 | Updated Information Regarding Maryland
Prescription Drug Monitoring Program

7 | Pharmacy and the Law

8 | Congratulations to the 2016 Graduating Classes

25 | Tne New Normal — DSCSA Compliance Tips:
Policy Matters

suolponeed

17
ADVERTISERS INDEX Continuing Ed
25)|,CE.Quiz
22 Corporate Sponsors
27

2 RJ. Hedges & Associates
15 EPIC Pharmacies
16 Pharmacists Mutual
24 Cardinal Health
20, HD Smith
27 Buy-Sell-A-Pharmacy

28 University of Maryland MARYLANDPHARMACIST.ORG 3

Executive Director’s Message

AREMACISy,

EST, 1882 MARYLAND PHARMACISTS ASSOCIATION

RYL

wna,
S

Noriyioo”

MPhA OFFICERS 2016-2017

Hoai-An Truong, PharmD, MPH, FNAP,
Chairman

Kristen Fink, PharmD, BCPS, CDE,
President

Cherokee Layson-Wolf, PharmD, CGP,
BCACP. FAPhA, Vice President

Matthew Shimoda, PharmD, Treasurer

David Sharp, PhD, Honorary President

HOUSE OFFICERS

Ashley Moody, PharmD, BCACP, AE-C,
Speaker

Richard Debenedetto, PharmD, MS,
AAHIVP, Vice Speaker

MPhA TRUSTEES

Mark Ey, RPh, 2017

G, Lawrence Hogue, BSPharm, PD, 2017

Wayne VanWie, RPh, 2018

Chai Wang, PharmD, BCPS, AE-C, 2018

Amy Nathanson, PharmD, BCACP, AE-C,
2019

Darci Eubank, PharmD, 2019

Rachel Lumish, ASP Student President
University of Maryland School of
Pharmacy

EX-OFFICIO TRUSTEES

Rondall Allen, PharmD, Dean
University of Maryland Eastern Shore
School of Pharmacy

Natalie Eddington, PhD, Dean
University of Maryland School of
Pharmacy

Anne Lin, PharmD, Dean
Notre Dame of Maryland University
School of Pharmacy

David Jones, RPh, FASCP, MD-ASCP
Representative

Celia Proctor, PharmD, MBA, MSHP
Representative

Mayrim Millan Barrea, ASP
Student President
Notre Dame of Maryland University
School of Pharmacy

Tolani Adebanjo, ASP Student President
University of Maryland Eastern Shore
School of Pharmacy

PEER REVIEWERS

W. Chris Charles, PharmD, BCPS, AE-C

Caitlin Corker-Relph, MA, PharmD
Candidate 2017

LCDR Mathilda Fienkeng, PharmD, RAC

Nicole Groves, PharmD

G. Lawrence Hogue, BSPharm, PD

Edward Knapp, PharmD, PhD

Frank Nice, RPh, DPA, CPHP

Hanna Salehi, PharmD, MLS

STAFF

Aliyah N. Horton, CAE, Executive
Director

Shawn Collins, Membership Services
Coordinator

We welcome your feedback and
ideas for future articles for Maryland
Pharmacist. Send your suggestions to
Aliyah Horton:

Maryland Pharmacists Association,
9115 Guilford Road, Suite

200, Columbia, MD 21046,

call 443.583.8000, or

email aliyah.horton@mdpha.com.

Special thanks to Graphtech, Advertising
Sales and Design

President’s Pad

Dear Fellow MPhA Members,

Hello Everyone! I hope you had a wonderful summer! It is
truly an honor and pleasure to serve the members of the
Maryland Pharmacists Association as President. I look forward
to this coming year.

I extend great appreciation to the new chair of the Past
President's Council Dixie Leikach for her many years of
service and leadership to MPhA. I also thank Hoai-An Truong
for his leadership this past year and for engaging with me to ensure a smooth
transition.

We had a very active year culminating in a fantastic 134'" Annual Convention, where
pharmacists from around the state convened to learn, network and celebrate the

notable accomplishments of our colleagues and friends. I hope you enjoyed yourself
at both the CE sessions and social events and enjoy looking at the recap in this issue.

As many of you know I place a high priority on mentoring pharmacy residents and
students to assist them in discovering the niche of pharmacy that inspires them, and
developing their leadership skills. As Pharmacists, we are natural leaders and key
contributors to excellence in patient care. By making connections with our fellow
colleagues and becoming actively involved in our profession through MPhA and the
MPhA Foundation, we can ensure that Maryland pharmacy remains strong, connected
and passionate about the work we do to serve the residents of Maryland, no matter
the practice setting.

This year, we will have many exciting opportunities to get involved and engage in
pharmacy and our greater community. I encourage you to take time to connect with a
committee or a cause, lend your voice, and encourage your colleagues to join MPhA.
The more diverse but united voices we have, the better MPhA will be able to serve
you, meet your needs and represent the profession on issues that impact our daily
ability to practice. Having worked in hospital, chain, managed care and independent
pharmacy, I understand the unique challenges and opportunities we face. Our
collective voice can serve to expand the role we play in patient care. I believe that we
are at a crucial tipping point for pharmacy, on the brink of achieving Provider status
which will allow us to provide comprehensive pharmacy services to an even greater
number of patients within our state. We have made significant strides in our legislative
efforts. By joining together to present one face for Pharmacy in Maryland we have

the power to continue to grow our profession in exciting new directions. At the same
time our active voice must also work to protect our ability to provide patient care ina
way the puts the patient first. MPhA is here to provide the professional development,
advocacy tools and resources to make this happen.

Get active, lend your voice, your expertise and experience. We will all benefit.
I look forward to working with many of you as we reconvene in the Fall.

Again, congratulations to all our award winners and others who received recognition
the Annual Convention. May they all inspire us! @

Sincerely,

Mec. WA, Eo Se
Kristen Fink
President

IMPORTANT Ee

UPDATED Information Regarding Marylan
Prescription Drug Monitoring Program

New law requires providers to REGISTER with and USE PDMP

The Maryland Prescription Drug Monitoring Program (PDMP) was created to support providers and their patients
in the safe and effective use of prescription drugs. The PDMP is part of Maryland's response to the epidemic of opioid
addiction and overdose deaths.

MARYLAND PDMP FACTS WHAT IS CRISP?
e Authorized by law in 2011 e State-designated health information exchange

e Maryland Department of Health and Mental Hygiene ae een? Hie ln seamen mele Sg amet
(DHMH) program Columbia.

e Electronic system connecting all 46 acute
care hospitals in Maryland

e Web-based portal gives providers secure CRISP
access to patient PDMP, hospital and other
clinical data

S
e Contains data on Rx controlled dangerous substances , ° 4N
(CDS) dispensed to patients in Maryland

¢ Providers get free, online access through Chesapeake
Regional Information System for our Patients (CRISP)

LEGAL CHANGES AFFECTING PROVIDERS
On April 26, 2016, Governor Hogan signed into law HB 437 which includes the following legal changes:
1. Mandatory PDMP Registration for CDS Prescribers & Pharmacists
Pharmacists: Licensed pharmacists in Maryland must be registered with the PDMP by July 1, 2017.

Prescribers: Beginning October 1, 2016, practitioners authorized to prescribe CDS in Maryland must be registered with the
PDMP prior to obtaining a new or renewal state CDS Registration (issued by the Division of Drug Control) OR by July 1,
2017, whichever occurs sooner. This applies to physicians, physician assistants, nurse practitioners, nurse midwives, dentists,
podiatrists and veterinarians. This mandate does not apply to nurses.

REGISTER NOW with the PDMP through CRISP at https://crisphealth.org/. Click on PDMP
‘Register’ button on the left-hand side of the screen. For registration help, call 1-877-952-7477.

2. Mandatory PDMP Use by CDS Prescribers & Pharmacists
Beginning July 1, 2018:

e Pharmacists must query and review patient PDMP data prior to dispensing ANY CDS drug if they have a reasonable belief
that a patient is seeking the drug for any purpose other than the treatment of an existing medical condition.

Prescribers must, with some exceptions, query and review their patient's PDMP data prior to initially prescribing an opioid
or benzodiazepine AND at least every 90 days thereafter as long as the course of treatment continues to include prescribing
an opioid or benzodiazepine. Prescribers must also document PDMP data query and review in the patient's medical record.

Information regarding Mandatory Use is available on the DHMH PDMP website. DHMH will provide additional information and
reminders closer to, but before the implementation date.

3. CDS Prescribers & Pharmacists May Delegate PDMP Data Access

Prescribers and pharmacists may delegate healthcare staff to obtain CRISP user accounts and query PDMP data on their
behalf. Delegates may include both licensed practitioners without prescriptive authority and non-licensed clinical staff that are
employed by, or under contract with, the same professional practice or facility where the prescriber or pharmacist practices.

TO LEARN MORE

Visit the DHMH PDMP website for updated information, important For more information about the opioid addiction and overdose

compliance dates and Frequently Asked Questions: http://oha.dhmh. epidemic in Maryland and what healthcare providers can do to help,
maryland.gov/PDMP. visit http://bha.dhmh.maryland.gov/OVERDOSE_PREVENTIOW/. S

MARYLANDPHARMACIST.ORG 5

Version 2.0, June 6, 2016

MPhA News

What has MPhA been doing?
Member Mentions highlighted below!

Congratulations to Kristen Fink and Andrew Wherley
Kristen and Andrew welcomed Baby Boy John Andrew Wherley on May 25, 2016. @

Maryland Appointees to APhA 2016-
2017 House of Delegates

The following MPhA members will serve

as the Maryland Delegation in the APhA
2016-2017 House of Delegates: G. Lawrence

Hogue; Brian Hose; Anne Lin; Ashley Moody;

Matthew G. Shimoda; Hoai-An Truong; and
Alternate: James Dvorsky @

Medical Mission Trip to Haiti

Hoai-An Truong and Frank Nice travelled
to Haiti with students from the University
of Maryland Eastern Shore on a pharmacy
medical mission trip. The mission brought
donated pharmacy and healthcare supplies
and assisted with ee care. @

See

sie

Source: Hoai-An Truong

6 MARYLAND PHARMACIST | SUMMER 2016

PHARMACY SCHOOL HIGHLIGHTS

Governor Larry Hogan Spring Visit to University of Maryland
Eastern Shore

President Juliette B. Bell, Dean
Rondall E. Allen, faculty and
students at the University of
Maryland Eastern Shore School of
Pharmacy and Health Professions
welcomed Governor Larry Hogan
and members of the Maryland
House and Senate to campus this LE EL,
past Spring. The visit was an nen to express ea iy for
funding the planned pharmacy and health profession facility for the
school. @

Elizabeth Seton High School’s Pharmacy Technician Training
Program Partners with Notre Dame of Maryland University
School of Pharmacy

Dr. Paul Vitale, Interim Chair & Associate Professor of Clinical &
Administrative Sciences was invited to assist Elizabeth Seton High
School in the evaluation of a pharmacy technician curriculum for its
new pharmacy technician training program. At his recommendation,
Dr. Barbara McHenry, a licensed pharmacist with over 35 years of
experience, was hired as the program coordinator. The program is
accredited by the Maryland State Board of Pharmacy. Dean Anne
Lin attended the White Coat Ceremony of the inaugural group of
students and Mr. Daniel Ashby, Senior Director of Pharmacy, Johns
Hopkins Hospital was the keynote speaker. Twenty-eight students
along with Dr. McHenry visited Notre Dame during the spring
semester and utilized the Pharmacist Care Lab facility for a three-
hour sterile preparations class. School of Pharmacy faculty along
with Dr. McHenry taught sterile technique. The School of Pharmacy
and Elizabeth Seton High School will explore further opportunities
for collaboration. Elizabeth Seton is the only college preparatory
high school in the state of Maryland that is officially accredited by
the Maryland State Board of Pharmacy for its Pharmacy Technician
Program. @

Pharmacy and The Law

By: Don. R. McGuire Jr., R.Ph., J.D.

This series, Pharmacy and the Law, is presented by Pharmacists Mutual
Insurance Company and your State Pharmacy Association through
Pharmacy Marketing Group, Inc., a company dedicated to providing quality
products and services to the pharmacy community.

NEW ADVANCES

We are entering another period of
change in the pharmacy profession.
We experienced such a period

during the 1990's when collaborative
practice and pharmacist-administered
immunizations were new topics of
conversation. Now we are seeing an
enhancement of pharmacist-provided,
patient-centered services. And these
changes are dovetailing with the drive
for provider status for pharmacists. |
remember performing kinetic dosing
for aminoglycosides at our hospital

in the 1990's. We were very proud of
how progressive and advanced we
were. Our results were improving our
patients’ outcomes. It was only later
that we discovered that collaborative
practice wasn't yet authorized by our
state practice act.

At the opposite end of the spectrum
from those who blindly race ahead are
those who resist such changes. These
are pharmacists who are comfortable
in their existing practices and are
worried about the extra liability when
performing new patient care services.
These extra liability concerns have
been discussed in previous articles.
Change and progress are necessary to
stay relevant and useful in the modern
world. The key to managing change is
preparation.

Ohio enacted a law at the end of

2015 that enhanced the ability of
pharmacists and physicians to enter
into collaborative practice agreements.
Among the authorities granted to
pharmacists are; ordering blood and
urine tests, analyzing those results,
modifying drug regimens (including
ordering new drugs), and authorizing
a refill of critical medications. Oregon

has a new law going into effect in
2016 which authorizes pharmacists
to prescribe self-administered oral or
transdermal birth control. California
has also passed a law similar to
Oregon's. Typically these statutes
authorize pharmacists to expand their
practices, but they do not require
them to do so. So how do you prepare
to expand your (and your patients’)
horizons?

Examine the new practices open to
you in your state. Which of them are
you currently competent to perform?
Which can you obtain addition
training relatively quickly and become
competent? Which ones best serve
the needs of your patients? Once you
know that, you can assess your liability
exposure in performing those services.
This is done by reviewing your legal
duties to your patients. What duties
are required for you to provide the
service? What possible ways could
those duties be breached? What
possible injuries could result from that
breach? In this way, you can evaluate
your exposure for providing any new
service.

Once you have decided to move
ahead, the next step in preparation is
to examine your insurance coverage.
You can't just assume that new
practices are covered. Individual
insurance companies can determine
what they do and do not want to
cover ina policy, regardless of what
constitutes the scope of practice in
your state. It is never safe to assume
that you have coverage for something
without first asking and validating
that with your insurance carrier. For
example, there are policies available in
the marketplace that exclude damages

resulting from patient counseling

— whether or not the counseling is
required by law. While we are talking
about optional activities and services
here, your insurance policy should
certainly cover the activities that you
are required to perform. To avoid
problems later, it is a good practice to
read your insurance policy to make
sure that it provides the coverage that
you need.

Once you have assessed your possible
exposure and verified your insurance
coverage, you are ready to begin
providing advanced services like those
authorized in Oregon, Ohio, California
and other states. You are part of the
next wave of change in pharmacy
practice. The profession of pharmacy
has come a long way in a relatively
short period of time. In the 1950's,

it was unethical to tell a patient the
name of their prescribed medication.
Now pharmacist are engaging in
extensive collaborative practices,
providing MTM and immunizations;
even prescribing medications whose
names they weren't allowed to disclose
a few years ago. It is an exciting time
to be a pharmacist! @

© Don R. McGuire Jr., R.Ph., J.D., is
General Counsel, Senior Vice President,
Risk Management & Compliance at
Pharmacists Mutual Insurance Company.

This article discusses general principles
of law and risk management. It is not
intended as legal advice. Pharmacists
should consult their own attorneys

and insurance companies for specific
advice. Pharmacists should be familiar
with policies and procedures of their
employers and insurance companies,
and act accordingly.

MARYLANDPHARMACIST.ORG 7

Congratulations to the 2016
Graduating Classes!

2016 University of Maryland School of Pharmacy Graduates

Solomon Tesfaye Abera
Sinthi Hau Acey

Naim Haque
Adrienne Isabella Herman

Oluwadamilola Oyinade Ademiluyi
Kenneth Odianosen Agboifo
Jihye Ahn

Rebecca Oluwatosin Akujor
Seid Beshir Ali

Meharie Getachew Aniley
Kevin Joseph Anthony
Tomefa Asempa

Marie Florence Atana Ebode
Lauren Barbour

Amanda Batdorf

Astrid Rocio Bernal

Michael David Boblitz
Samuel Thomas Brackett
Kelcymarie June Bye

Maria T. Cam

Dianna Lea Williams Campbell
Nicole Caprio

Natalia Victor Ceaicovscaia
Wai Lap Chan

Wai-Yee Chan

Chun-Wei Chen

Jonathan David Chen
Tatiana Petrovna Chentsova
Andrea Wing-Yun Cheung
Boradette Evelyn Chhuan
Yiu-Cheung Frederick Chim
Jane Ching

Brittany Carroll Couto
Moses Oluyanju Demehin
Anupama Divakaruni
Laurence Megne Djatche
Jeanne Diem Ngoc Do
Christine Duan

Emily Elizabeth Dunn
Jasmine Monique Ebron
Emmanuel Kelechi Ezedike
Opeoluwa Innocent Fagbemi
Carly Nicole Fisher
Christina Ebune Fomuso
Batsheva Beth Frank

Miguel Julio Franquiz
Joseph Adam Goble
Michael Ross Goldenhorn
Nancy Guan

Lauren Catherine Haggerty
Lucy Jeamin Hahn

Mahya S. Hajghassem

Yaa

Grace K. Herr
Chi-Cheng Michael Ho
Rebecca Rose Hollins
Alexandra E. Holmes
Chih-Wei Hsu

Suzan Hua

Helen Ping Huang
Sara Yun-Sang Huh
Violet Enjeh Igwacho
Iftekharul Islam
Anthony Hai Jiang
Peter James Kaiser
Yevgeniya Kalinina
Ashini Ashwin Kapadia

Deekshith Kumar Reddy Katta

Kristine Lee Keller

Jason Cho Ho Keung

Amana Khatun Khondaker

Vista Khoshroo
Caroline Eli Kim
Chanbin Kim

Diane Sookyeon Kim
Hae Young Kim
Hyunah Kim

Monique Boyun Kim
Myung In Kim

So Yung Kim

Stephanie S. Kim

Elle Rachel Kline

Niki Koirala

Da-Hye Koo

Alexander David Kravetz
Courtney Marie LaCotti
Jung Min Lee

Mark Kiwon Lee

Rosa Jisun Lee

Mary Lan Li

Eunhee Lim

Liming Lu

Zheng Luo

Minh Thao Hoang Luong
Stanley Wing Luong

Vi Thanh Luong

Archana Arvind Manerikar

Justin Elijah Martin
Melissa Marie McCarty
Christine Meaux

8 MARYLAND PHARMACIST | SUMMER 2016

Dianna Naree Kenner-Staves

Lindsey Ann Mileto
Emilija Miljkovic Renke
Kelly Christina Moore
Sheheryar Muhammad
Sharon S. Na

Sharina Nandwani

Kevin Khun Ngo

Anh Nguyen

Francis Nguyen

Jamie K. Nguyen

Natalie Dan Nguyen

Vy Lam Nguyen

Salin Nhean

Andongfac Nkobena
Nnamdi Francis Ofoegbu
Chikezie Obinna Okoro
Peace Anya Oluchi Siyou
Abdulafeez Ayodeji Oluyadi
Innocent Fowah Ongey
Inhuoma Uzochi Onyewuchi
Shannon Marie Osbome
Mirian Paik

Paulomi Tapan Patel
Ngoc Thi Thanh Pham
Joshua Charles Pozanek
Holly Suzanne Robertson

Daniel Shu

Andrew Michael Shuler
Steven Earl Sligh
Stephanie Ann Smisko
Rachel Denise Smith
Chenxi Song

Yong Eun Song
Christopher Olen St. Clair
Sheema Sultana

Melody Wen Sun

Bilal Tariq

Saad Tariq

Kara Leigh Tarr

Selimene Stephanie Tenkeu
Veronica Lee Timmons
Hung Vinh Truong

Lena Truong

Brian Lao Ung

Vorleak Vuth

Erick Tristam Warwick
Hailu Gebremichael Weldesenbet
Kacie Renee Whitty
Daniel Young Yi

YeSeul Yoo

Phillip Alexander Young
Shannon Nicole Zakielarz

Abdihakim Abdullahi
Lidia Abrahalei
Faroog Adetola
Oluwasegun Akinola
Akwaugo Amuchie
Bart Anderson
Chinonso Asiegbu
Victona Asoya

Eric Assah

Louiza Bako
Vernon Bitkeu Biali
lelissa Buff

Ikjae Chin

Zehra Demir
Emanga Ekinde
Marwa Elfadaly
naemeka Emenari
Alison Forrest
Mineille Gakuu
Sahr Gbakima

Phu Ha

April Hartford

PEeeRReeee

Wajiha Abdallah
Reem Abdullah
Camille Agosto
Monica Aguilar
Sharon Ahem
Jennifer Aiken
Betel Ali

Aisha Amin
Rachel Arasteh

Blair Heckel
Ryan Hines
Kristen Kas
Keesha Kline
Priyana Kumar

~
Te TI ET rg NE et Pe ETE ALI ATPL LS ACL

Alexandra Ashworth
Spencer Banks
Yvette Bonsu

Laura Maurin
Sheena Chou
Armstrong Chu
Katlyn Combs
Amber Connelly
Dwan Dalton

Long La

David Leach

Yinyin Li

Jessica Marcelin
Maryam Messforosh

a FT

Long Dang

Melanie Elliott

Richard Ewusie-Monney
Christina Haddad
Robbie Jean Hartwell
Charlotte Hunt

Ifeoma Ibe

Jazmine Johnson
Hannah Kang

Emily Mills

Katelyn Mitchell
Fistume Mulatu
Chukwuemeka Nwosu
Anuoluwapo Olofinlua
Nnamdi Onwuzu
Kapil Patel

Amanda Richards
Deborah Sarmiento
Hilary Schlerf
Soumil Sheth
Tiffanie Taylor
Dallas Tolbard
Salematou Traore
Henry Uwalaka
Vincent Vo
Alexander Walk
Joanna Wilhelmi
Melikte Woldeyesus
Jin Xu

Richard Yim

Hope Kares

Tae Lee

Adda Massah-Diagne
Benora McBride
Trudy-Ann McMillian
Margaret Moucheron
Hwan Namkung
Marcelia Ngaujah
Danh Nguyen

<hai Nguyen

Nghia Nguyen
Jaclyn Niggemyer
Hannah Pak Noh
Adeola Oluwatimilehin
Atinuke Omolara
Eseohen Osunde
Chirag Pancholi

Ju Hyung Park
Anokhi Patel
Dhrumil Patel

Sandy Phung

Hera Saleem

Farid Salehani
Rasoul Samadani
Shauna Smith

Sean Stewart
Michelle Mae Tandoc
April Tepfer

Brittany Thomas
Tram Tran

Amanda Welk

Jude Wenerick
Ashley Yee

Doo Young Yoo

MARYLANDPHARMACIST.ORG

Annual

Convention Q

10 MARYLAND PHARMACIST | SUMMER 2016

DMPh

@OMPh

@ MPh

@MPh

Cover Story

134" Annual

Convention

Martha N. Bryan

The Opening Session Speaker at the 134" Annual Convention presented on Keeping Cool, Calm &
Collected when the Pressure is On. This article is provided as a follow-up to her presentation and
iS DED CARED MOsiTOSEWHO WANTETO.GERMORE LIFE OUT OF LIFE!

All of us want to live longer and enjoy life more, but in
our search for healthier living we have overlooked the
most important element. Each year we spend more and
more money on diets and diet pills, exercise programs,
wellness books and videos, vacations, and health club
memberships; but the key to a healthy, happy life is to
“enjoy our work.” When we are fully engaged in work we
enjoy, we are at our very best, we are happiest, and we
are healthiest.

George Bernard Shaw said, “A master in the art of living
knows no sharp distinction between their work and their
play, their labor and their leisure, their mind and their
body, their education and their recreation... They simply
pursue their vision of excellence through whatever they
are doing and leave others to determine whether they
are working or playing.” John Gardner in his book Self -
Renewal said, “The last day you will ever work is the day
before you fall in love with whatever you are doing for a
living.” |
When a person is making a success of something, it is
not work — it is a way of life.

A survey asking people to select the top ten business
people America produced in the past 200 years
concluded that the average age of death for achievers
like Ford, Bell, Sanders, and Penney was 87. These people
were all in professions that are considered to be highly
stressful, but each found tremendous: a their work.

se Gre Know ‘what

People who.enjoy their workare. th

they want and deliberately do tt the > things that will lead to. =

MEDICATION AFFORDABILITY

The Maryland Pharmacist Association
supports efforts to limit unjustified

or unreasonable pricing by
pharmaceutical companies that may
affect the affordability of medications
for patients.

getting them what they want. They put their whole heart
and soul into using their unique talents and abilities to
make a difference in the world.

Health c comes from the direc tion in whict 1 we are
moving. We are happiest when we are thinking
planning, working, and climbing in purs
goals. We are at our best emotionally, mentally, and
physically when we are on the road to somet
want to bring about

ult of our own

hing we

Health and happiness comes when we dedicate
ourselves to the development of our natural talents and
abilities.

And, health comes by doing what we love to do and
doing it better and better in service to others.

To make that happen, we need to commit ourselves to
a cause that is greater than us. We will need to fill our
thoughts with purpose, our future with a plan, our days

swith work, our leisure with good friends and family,

and our mind with good memories. That is to have
succeeded! @

AUTHOR

Martha N. Bryan, Bryan & Bryan Associates
marthabryan@bryanandbryanassoc.com
3521, - 105th Place SE,.Everett WA 98208

425 - 337 - 1838 *** Fax 425 - 338 - 4509

www.bryanandbryanassoc.com

PHARMACISTS ROLE IN NALOXONE
The Maryland Pharmacist Association supports:
1. Training all pharmacists to administer naloxone

2. Training all pharmacists to teach the public to administer naloxone

3. Dispensing naloxone to patients and those associated with persons at
risk for opioid overdose.

4. Educating patients and the public to reduce the risks of opioid misuse.
MARYLANDPHARMACIST.ORG 11

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FH fra LF? A a2 » & 4 , D> ar Ba rf = =: Ga Bh 04> 0 , § oe gm
2ZOT6R Awaras ana ReECOGaniItions
y, Od i> ee WW Ooo @ | ' Lo atwonh MB OA@ GE. Bais, )

Goa~W tw vy Get Wes GTEC Tw wey ba | BRR IR ww

Bowl of Hygeia Award presented to
Ellen H. Yankellow, PharmD.

Established in 1958, the Bowl of Hygeia Award
recognizes pharmacists who possess outstanding
records of civic leadership in their communities and
encourages pharmacists to take active roles in their
communities. In addition to service through their
local, state, and national pharmacy. associations, award
recipients devote their time, talent, and resources to a
wide variety of causes and community service.

The Bowl of Hygeia is the most widely recognized
international symbol for the pharmacy profession and
is considered one of the profession's most prestigious
awards. Sponsored by Boehringer Ingelheim, American
Pharmacists Association and the National Alliance of
State Pharmacy Association.

e All awards presented by MPhA President
Hoai-An Truong, unless otherwise noted. @

Excellence in Innovation Award,
sponsored by

Upsher-Smith Laboratories
and the MPhA Foundation,
presented to Yen Dang, PharmD

MPhA Mentor Award Distinguished Young
presented to Pharmacist Award, soonsored

James Bresette, by Pharmacists Mutual
PharmD Companies, presented to

Ashley E. Moody, PharmD,

BCACP. AE-C

12 MARYLAND PHARMACIST | SUMMER 2016

aay
Pharmacist Advocate Awa.
sponsored
Buy-Sel/-A-Pharma
presented
Murhl Flowers, R.

Calamatn =a DA

salematou Traor olen Gh
A | +h A/ lt ( A
Aliyah INV. Ho! LOl), CAE

Salematou Traore, PharmD, University of Maryland Eastern
Shore School of Pharmacy

Michael Goldenhorn, PharmD, University of Maryland School
of Pharmacy

Nghia Nguyen, PharmD, Notre Dame of Maryland University
School of Pharmacy

Pn a er ere ON te ee
Michael Goldenhorn, PharmD with

[7 ~~ LAA tomy

MPhA Scholarship - Brian Lindner, University of Maryland Dean Natalie Eddingtc
School of Pharmacy

MPhA Scholarship - Geoffrey Saunders, University of
Maryland Eastern Shore School of Pharmacy

MPhA Foundation Scholarship - Tolani Adebanjo, University
of Maryland Eastern Shore School of Pharmacy

Cardinal Health Generation Rx MPhA Seidman Distinguished
Champions Award, Achievement Award presented to the House Recognit
sponsored by Cardinal Health G. Lawrence Hogue, BS Pharm, PD presented
Foundation, presented to W. Christopher Charles F Dy jei6

Tali Johnson, PharmD (righb by Honorary President -

insert name David Sharp PhD (no picture)

MARYLANDPHARMACIST.ORG 13

Cover Story

Thank you to all the supporters and
contributors who assisted in making the
134 Annual Convention a success!

CONVENTION PLANNING COMMITTEE
Chair: Darci Eubank

Committee Members: Nicole Culhane,
Kristen Fink, Sara Hummel, Lauren Lakadawla,
Cherokee Layson-Wolf, Christine Lee-Wilson,

Dixie Leikach, Sara Martin, Marie-Therese Oyalowo,

Deanna Tran, and Hoai-An Truong.

PHOTOGRAPHERS AND VIDEOGRAPHERS
Arnie Honkofsky, Bonnie Li-Macdonald, and
Deanna Tran

CONVENTION SPONSORS
Asthma and Allergy Network
HD Smith

Infinitrak

Maryland P3 Program

MPhA Foundation
PharmCon/FreeCE.com
Program Management Services, Inc.
Shoppers Pharmacy
Whitesells Pharmacy

Your Community Pharmacy

EXHIBITORS

American Associated Pharmacies
Amerisource Bergen
Boehringer Ingelheim
Calmoseptine, Inc.

Cardinal Health

CVS Health

HD Smith

Infinitrak

Kaiser Permanente

Maryland Board of Pharmacy
Pfizer

McKesson

MPhA Foundation

Notre Dame of Maryland Sg 4 * 4

Novo Nordisk Inc.
Nutramax Laboratories Consumer as nc.

Pharmacist’s Education Advoéac

14 MARYLAND PHARMACIST | SUMMER 2016

, SouneiM(PEAC)™ =
PEER (Pharmacy Ethics, Education & Resouitces) ie

EXHIBITORS (continued)
PharmCon Inc./FreeCE .com
Pharmacists Mutual Companies
QS1
Rite Aid
Smith Drug Company
University of Maryland Eastern
Shore School of Pharmacy
University of Maryland School of Pharmacy

GIVEAWAYS AND SAMPLES CONTRIBUTORS
Calmoseptine, Inc.

Commission for Certification in Geriatric Pharmacy
EPIC Pharmacies

Hisamitsu America, Inc.

Infinitrak

Mission Pharmacal Company

Pharmacists Mutual Companies

Rx Systems Inc.

Target Marketing

University of Maryland School of Pharmacy
Aimprint

® MARYLAND PHARMACISTS ASSOCIATION
FO.U NLD A Ph ON

Thank you to the following sponsors and
contributors for your support of the 2016

Barry Poole Memorial Golf Tournament, which
benefitted the programs and services of the
MPhA Foundation.

Apple Discount Drug
Deep Creek
Healthsource Distributors
Klein's ShopRites of Maryland
Nutramax Labs
Pharmacists Mutual Companies

Chairman: Hoai-An Truong, PharmD, MPH
President: Kristen Fink, PharmD, BCPS, CDE

Vice President: Cherokee Layson-Wolf, PharmD, CGP,
BCACP, FAPhA,

Treasurer: Matthew Shimoda, PharmD
Honorary President: David Sharp, PhD

Speaker: Ashley Moody, PharmD, BCACP, AE-C

Vice Speaker: Richard DeBenedetto, PharmD, MS, AAHIVP

S
=
=
>
=
=
=
=
=
=
—
—
—

Mark Ey, RPh « G. Lawrence Hogue, BS Pharm, PD
Wayne VanWie, PD « Chai Wang, PharmD, BCPS, AE-C
Amy Nathanson, PharmD, BCACP, AE-C

Darci Eubank, PharmD

UM ASP President: Rachel Lumish

NDMD SOP: Anne Lin, Dean

UMES SOP: Rondall Allen, Dean

UM SOP: Natalie Eddington, Dean

UMES ASP President: Tolani Adebanjo
NDMU ASP President: Mayrim Millan Barea

MPhA Foundation: Paul Holly

We Deliver Solutions for

a Healthier Bottom Line

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Membership offers:

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MARYLANDPHARMACIST.ORG 15

Endorsed’ by:

MARYLAND PHARMACISTS ASSOCIATION

Our commitment to quality
means you can rest easy.

Learn more about Pharmacists Mutual’s solutions for you —
contact your local field representative or call 800.247.5930:

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When to Say When:

The Use and Overuse of Oral Proton
Pump Inhibitors

Priya Rajendran, PharmD Candidate 2017
Mary Lynn McPherson, PharmD, MA, BCPS, CPE
Professor, Executive Director Advanced Post-Graduate Education in Palliative Care
University of Maryland School of Pharmacy

Introduction

Proton pump inhibitors are among the most widely prescribed drugs worldwide, and in the United States.!

They are the third most widely sold drug class, with annual sales of $13.9 billion. In comparison to other acid-
suppressing medications, such as histamine-2 (H2) receptor antagonists, proton pump inhibitors (PPI) are
considered to be more potent at effectively inhibiting acid secretion. PPIs work to suppress gastric basal and
stimulated acid secretion by irreversibly inhibiting the H+/K+ ATPase pump located on the basolateral side of

the parietal cell, resulting in prolonged duration of activity (up to 3 days).* Proton pump inhibitors are now FDA
approved for healing erosive esophagitis (EE), maintenance of healed EE, risk reduction for development of gastric
ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs), short-term treatment and maintenance of
duodenal ulcers, pathological hypersecretory diseases such as Zollinger-Ellison (ZE) syndrome, and as a part of a
multidrug regimen for Helicobacter pylori eradication (Table 1).°*

As aresult of being well tolerated and highly effective, PPIs have become one the most prescribed classes of
medications in primary and specialty care, and over-the-counter availability has further increased their use.’
However, overuse of these medications occurs as many patients continue to take a PPI beyond the recommended
duration of therapy. Consumers often take an over-the-counter PPI without an initial or follow-up assessment, and
continue therapy beyond the recommended course of therapy. With long-term use (4 months to >2 years), there
are many different side effects that can occur such as atrophic gastritis, carcinoma, Clostridium difficile associated
disease (CDAD), fractures, hypomagnesemia, interstitial nephritis and vitamin B12 deficiency.* These adverse effects
can result in long-term complications requiring hospitalization and/or worsening of other co-existing conditions.

Last, there are various studies showing that no PPI is considerably clinically superior to another; however, there are
large price differences among this class of medications. With OTC formulations on the market, now there are much
more affordable options available to patients.

Learning Objectives
After reading this article, the learner will be able to: Key Words

1. List proton pump inhibitors on the market and differentiate ¢ Proton pump inhibitor (PPI)
between prescription and nonprescription formulations. Acid-suppressing » Omeprazole

2. List the indications for available proton pump inhibitors and Lansoprazole * Dexlansoprazole

recommended duration of therapy for each indication.

Esomeprazole e Pantoprazole
Rabeprazole e GERD
Adverse effects

3. Describe and explain adverse effects from long-term use of proton
pump inhibitors and the proposed mechanisms of action.

4 Given a patient case, select a proton pump inhibitor and provide
three patient counseling points.

MARYLANDPHARMACIST.ORG 17

Sidebar Case

Prescribing Considerations

You're working in your pharmacy one day when RJ, a 58 year-old overweight man approaches the pharmacy counter, and
tosses down a box of Prilosec OTC. "This is the FIFTH time I've had to buy this stuff for my indigestion. Why isn't it working?"
When you question him, he says that most days he experiences a burning sensation behind his breast bone, and occasionally
up his neck. At least several times a week he burps and has acid regurgitation. He frowns when he admits, “Sometimes the chest
pain is so severe I worry I'm having a heart attack.” He states he has taken four, two-week courses of Prilosec OTC in the past
four months (with a two-week hiatus in between courses) and it doesn't seem to be helping. He says he feels a little better while
he's taking the Prilosec OTC, but the symptoms go back to baseline severity during the two-week hiatus.

What is your assessment of RJ’s symptoms as he’s
described them?

a. Typical symptoms of simple heartburn

b. Sounds like simple heartburn and possibly
gastroesophageal reflux disease (GERD)

c. Symptoms seem suggestive of peptic ulcer disease

d. Symptoms are classic dyspepsia only

Adverse Effects
Vitamin Bi2 Deficiency

Although there is not enough evidence that proves

a direct correlation between vitamin B12 deficiency
and long-term (>2 years) proton pump inhibitor use,
some studies have shown that there may be evidence
of an association. Gastric acidity and pepsin enable
the release of ingested vitamin B12 from its protein-
bound state; subsequently through a series of steps,
vitamin B12 is ingested through the terminal ileum via
intrinsic factor°. Since gastric acidity is involved in the
initial cleavage of vitamin B12, there may be a link of
long-term proton pump use and Bi2 deficiency. This,
however, may not create an issue in normal, healthy
adults that have a large functional reserve of B12
because the usual human diet contains more B12 than
required.° Patients on long-term proton pump inhibitor
therapy can also still produce intrinsic factor which
allows for reabsorbing enterohepatically-recycled
cyanocobalamin and retaining ability to absorb
unbound cobalamin.° Problems with B12 deficiency
may become an issue for elderly patients who have

a higher prevalence of vitamin B12 deficiency, those
who are malnourished, and individuals with lower B12
SLOTES.

Clostridium-difficile associated diarrhea

Clostridium difficile is an anaerobic, spore-forming
bacterium that is a leading cause of nosocomial
infectious diarrhea in adults.®° Though the exact
mechanism is unclear, it is proposed that proton pump
inhibitors increase the pH of the stomach, allowing

for bacteria overgrowth and increased risk of infection

18 MARYLAND PHARMACIST | SUMMER 2016

The burning sensation and movement toward the neck are
suggestive of simple heartburn. However, RJ also states he has
acid regurgitation several times a week which suggests GERD.
Therefore, the correct answer is B.

Do you recommend RJ purchase this box of Prilosec
OTC for the fifth time?

a. Yes

b. No, he should switch to lansoprazole 15 mg (Prevacid
24HR)

by many different pathogens including Clostridium
difficile ®’ Bacterial overgrowth increases the level of
unconjugated bile acids in the stomach which in turn
support the conversion of ingested C. difficile spores to
the more virulent vegetative form.° Mild to moderate

C. difficile symptoms include mild to moderate

watery diarrhea without blood, along with abdominal
cramping; however more severe cases can include
symptoms of fever, malaise, and high-volume diarrhea.®
As the infection becomes systemic, more serious
complications include pseudomembranous colitis and
sepsis.® The risk for C. difficile infection is the greatest
for patients who are chronically ill, immunosuppressed,
and/or on antibiotic therapy, especially in the inpatient
setting.? Long-term use of PPI therapy should be
evaluated especially in cases of serious or recurrent
enteric infections if there is no urgent indication for
acid suppression.°® If possible, use the lowest dose and
shortest duration of PPI therapy appropriate for the
condition being treated.®

Carcinoma

Although the risk of developing gastrointestinal
cancer from proton pump inhibitors is extremely

low especially in patients without H. pylori infection,
long-term proton pump inhibitor use with H. pylori
infection is associated with gastric inflammation and
development of atrophy.° Acid-suppressing drugs
such as PPIs alter the gut environment through acid
suppression, thereby increasing the pH of the stomach.’
The more alkaline environment of the stomach allows
for bacterial growth which can cause inflammation

of the stomach and altered signaling between cells of
the stomach.’ Two cells involved in cell signaling and

c. No, he should switch to omeprazole 20 mg/sodium
bicarbonate 1100 mg (Zegerid)

d. No, he should be referred to his primary care practitioner

RJ is a mess! Five courses of Prilosec OTC? Clearly this isn't
getting the job done. Actually RJ has several contraindications
to self-treatment including the following:

e Frequent heartburn for more than 3 months

¢ Heartburn while taking recommended dosages of
nonprescription PPI therapy

e Severe heartburn and dyspepsia

RJ should be referred to his primary care provider at this time
and he should NOT purchase the Prilosec OTC. Therefore, the
correct answer is D.

Several weeks later RJ returns to the pharmacy with a
prescription for a PPI. He tells you he’s had several medical
tests and it seems that he has severe reflux disease. The
doctor told him he would be taking this prescription PPI for

production of gastric acid are: enterochromaffin-like
cells (ECL cells) and gastrin-producing cells (G cells).°
Enterochromaffin-like cells are located beneath the
epithelium of gastric glands of the gastric mucosa that
aid in gastric production via the release of histamine
on parietal cells.? Gastrin-producing cells, located in
the stomach antrum, produce gastrin which serves

2 functions: first, to stimulate ECL cells to produce
histamine, and second to directly stimulate parietal
cells to produce hydrochloric acid.’ In the presence of
acid-suppressing drugs, G cells continually produce
gastrin which acts on ECL cells and can lead to
hyperplasia and further to form liner hyperplasia,
micro-carcinoids, and carcinoids.’ Gastrin's action on
parietal cells can lead to hypertrophy and hyperplasia.’

Fractures

A large nested case-control study conducted by Yang
et al. showed the risk of hip fracture was significantly
increased among patients on long-term high dose
PPIs; the strength of the association increased with
increasing duration.’° Short-term use of PPIs (less than
1 year) regardless of the daily dose is not associated
with increased risk of fractures. The theory supporting
this association is that an acidic environment in the
stomach facilitates the release of ionized calcium

from the insoluble calcium salts into soluble calctum
salts which then can be absorbed." This proposed
theory, however, does not account for ingested soluble
calcium; further, PPI therapy may only hinder calcium
absorption taken without a meal.” The risk for fractures
seems greater in patients already presenting with a

risk factor such as those who are elderly, on long-
term steroid therapy, and those with osteoporosis."

the foreseeable future. RJ asks “My wife checked this out on
the computer, and she’s worried about the side effects if I
keep taking this medicine. Should I be worried?”

Which of the following MAY be adverse effects
associated with long-term PPI therapy?

a. Vitamin B12 deficiency

b. Clostridium-difficile associated diarrhea
c. Fractures

d. Hypomagnesemia

e. All of the above are POSSIBLE side effects; encourage RJ
to keep all appointments with his primary care provider

As you read in this article, all of the adverse effects shown
above have been associated with PPI therapy. This doesn't
mean RJ will necessary develop any of these, or other adverse
effects associated with long-term PPI therapy. Of course it’s
advisable that he keep all follow up appointments with his
primary care provider. Therefore, the correct answer is E.

Given the significant morbidity and mortality from
hip and other fractures, providers should weigh the
risk and benefits of PPI in vulnerable patients.° It is

recommended to use the lowest effective dose for the
shortest duration of time, and to supplement vitamin
D and soluble calcium in the form of citrate rather than
insoluble calcium carbonate.*"°

Hypomagnesemia

Although hypomagnesemia is very rare with PPI

use (less than 30 cases since 2006), it is suggested
that the possibility of hypomagnesemia is greater
with long-term use of PPIs.° A few patients with
hypomagnesemia received PPIs for only 1-2 years,
but most cases were associated with long-term PPI
use: 17 of 28 patients (61%) had received PPI therapy
for five or more years and eight (29%) for at least 10
years.° Normalization of plasma magnesium levels
occurred after PPI discontinuation and reoccurred
with days after restarting PPI.1° Although the

exact mechanism is unclear and there are many
proposed theories, it is thought that PPIs might
impair the paracellular transport of magnesium by
altering intestinal permeability and tight junction
function.? Hypomagnesemia may be symptomatic
or asymptomatic; severe cases may cause tetany,
seizures, and cardiac arrhythmias.’ Providers should
consider obtaining serum magnesium concentrations
prior to beginning long-term therapy, especially if
taking concomitant digoxin, diuretics, or other drugs
known to cause hypomagnesemia; and periodically
thereafter.°*

MARYLANDPHARMACIST.ORG 19

Acute Interstitial Nephritis (AIN)

A nationwide nested case-control study in New

Zealand completed by Blank et al showed omeprazole,

pantoprazole, and lansoprazole were associated
with a significantly increased risk of acute interstitial
nephritis resulting in hospitalization compared with
past use.'° Although the risk was low, the risk was
substantially higher in older users.’° The mechanism
of AIN is unknown and appears to be an idiopathic
hypersensitivity reaction with no relation to dosage,
latency, time to recovery, age, or gender.’* Acute
interstitial nephritis (AIN) is characterized by the
presence of an inflammatory cell infiltrate in the
interstitium of the kidney. Patients with AIN present
with nonspecific symptoms of acute renal failure
including oliguria, malaise, anorexia, nausea and
vomiting.“ PPI therapy should be discontinued if AIN
develops.

Heartburn
(OTC — 14 days)

H. pylori eradication
(10-14 days)**

(3-6 months)

Proton Pump Inhibitor Indications

i
(4-8 weeks)

3
(4-8 weeks)
(4-8 weeks)
(4-8 weeks)

NSAID associated gastric ulcer prophylaxis

Differentiating between PPIs

Proton pump inhibitors on the market are all similar
in terms of chemical structure and mechanism of
action. The PPIs differ in their pKa, bioavailability, peak
plasma levels and excretion which can elicit different
characteristics that may align with patient preferences.
Lansoprazole/dexlansoprazole and pantoprazole have
been shown to be the most bioavailable with the
highest plasma levels. Rabeprazole has a slightly faster
onset of action due to its pKa whereas pantoprazole

is considered the most “gastro-specific” because of its
binding to cysteine residues 813 and 822 within the
alpha-subunit of the proton pump.’* However, the
clinical relevance of these differences has not been
established.’

A number of studies have evaluated differences
between PPIs and although some show that one
PPI may be slightly superior to another PPI, the

Table 1 - Indications and Approved Duration of Therapy for PPis*'*

Kole
Xi RX
X | X

=| |_| esomeprazole

CPx] [| zeseria
T= == =|] taoprasote
aa

=| SSS] crerasat

Pathological hypersecretory conditions X X X 1X
(as long as clinically indicated)

eS eee

Risk reduction of upper GI bleed in critically ill patients X
(14 days)

*Injection only. For risk reduction of rebleeding in patients postendoscopy for acute bleeding gastric or duodenal

ulcers in adults.

**May require additional treatment duration depending on regimen.

20 MARYLAND PHARMACIST | SUMMER 2016

Table 2 - Proton Pump Inhibitor Prescribing Information?"5

Generic
Rx/OTC
Generic
Product

Formulations
Dose Range
(mg)/once
daily
Administration
Combination
Monthly Cost

Capsule ae aie .
ays (Rx
Omeprazole Prilosec i Yes Packet 20-40 ral Zegerid uf
CC. Suspension $20 14/
Ue 28 days (OTC)

Capsule
Suspension
Tablet

‘ Rx
ih é

Dexlansoprazole

Esomeprazole Nexium

Pantoprazole

$176.90/
30 days (Rx)
15-30 Oral Prevpac
$10.67/
14 days (OTC)

30 days (Rx)

Capsule aanmeae
Packet Oral Vimovo SNE
; 20-40
IV Solution IV $9.84/
Tablet 14 days (OTC)

Packet
Tablet abe S368.22/
IV Solution

te 90 days (Rx)

Tablet $343. -
Rabeprazole Aciphex Rx Yes 20-60 Oral
*Prices based off of minimum dose of generic and OTC formulation.
PharmCon is accredited by The authors have no financial disclosures (2) Scroll down to Homestudy/
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The Use and Overuse of Oral Proton

This program provides for 1.0 contact Pump Inhibitors can be found online Note: If this is not the first time you are
hour (0.1) of continuing education at www.PharmCon.com. signing in, just scroll down to Homestudy/
credit. Universal Activity Number (UAN) (1) Click on ‘Obtain Your Statement of OnDemand CE Credits and select the quiz

0798-9999-16-106-H01-P you want to take.

CE Credits for the first time.

CE Questions Answers from page 23
Tite) C,5).0;.4)' Ex5))A76):A2-7) A-S)D;°9).C:10) D

MARYLANDPHARMACIST.ORG 21

magnitude of the difference is small and of uncertain
clinical importance.” Any difference in efficacy may

not warrant a change in PPI when considering cost-

effectiveness. Table 2 compares the PPIs including
generic availability, prescription/non-prescription
status, frequency of use, and the average monthly
cost.'® As expected, non-prescription or generic
equivalents are less expensive than branded products.
Nonprescription PPIs may be beneficial for consumers
who do not have prescription coverage or occasional
heartburn (<2 days/week) and are just as effective as

more expensive prescription alternatives.

Conclusion

Given the potential for long-term side effects, it is
important for healthcare providers to consider the

following regarding PPI therapy:

e Assess whether there is an indication for a PPI

risk patients

¢ Periodically assess PPI dosage and frequency
e Assess whether the treated condition is improving

¢ Consider vitamin supplementation in elderly or at-

e Reassess whether PPI therapy is still appropriate or
should be discontinued.

If there is no longer an indication for PPI use, the PPI
should not be discontinued abruptly as rebound acid
hypersecretion and reflux can occur. Instead, the

PPI dose should be decreased slowly over a period

of time. For example, if the current dose is 40 mg of
esomeprazole (Nexium) once daily, the dose can be
reduced initially to 20 mg once daily for 2-3 weeks.
After the patient is stabilized on this dose, the PPI can

be switched to an H2 antagonist such as ranitidine 150
mg twice daily. For additional relief of GERD symptoms

or gas, over the counter antacids and simethicone may

supplement the regimen. @

References

ile

Chubineh, S., & Birk, J. (2012). Proton Pump
Inhibitors: The Good, the Bad, and the Unwanted.
Southern Medical Journal, 105(11), 613-618.
Retrieved February 24, 2016, from http://sma.org/
wp-content/uploads/2012/11/November_Article.
pdf

Shin, J. M., & Sachs, G. (2008). Pharmacology of
Proton Pump Inhibitors.Current Gastroenterology
Reports, 10(6), 528-534

Lexicomp Online®, Lexi-Drugs®, Hudson, Ohio:
Lexi-Comp, Inc.; February 18, 2016.

Proton Pump Inhibitors: Use In Adults. (2013,
August). Retrieved February 20, 2016, from
https://www.cms.gov/Medicare-Medicaid-
Coordination/Fraud-Prevention/Medicaid-
Integrity-Education/Pharmacy-Education-
Materials/Downloads/ppi-adult-factsheet.pdf
Sheen, E., & Triadafilopoulos, G. (2011). Adverse
Effects of Long-Term Proton Pump Inhibitor
Therapy. Digestive Diseases and Sciences

- Springer, 56, 931-950. Retrieved February

24, 2016, from file:///Users/priyarajendran/
Downloads/adverse effects of long term proton
pump inhibitor therapy.pdf.

MPhA News

WELCOME
NEW MEMBERS

10.

slate

Mayo Clinic Staff. (2013, July 16). C. difficle
infection. Retrieved February 26, 2016, from
http://www.mayoclinic.org/diseases-conditions/
c-difficile/basics/definition/con-20029664

Clooney, A. G., Bernstein, C. N., Leslie, W. D.,
Vagianos, K., Sargent, M., Laserna-Mendieta, E.
J., Claesson, M. J. and Targownik, L. E. (2016),
A comparison of the gut microbiome between
long-term users and non-users of proton
pump inhibitors. Alimentary Pharmacology &
Therapeutics. doi: 10.1111/apt.13568

Lexicomp Online®, Infectious Diseases, Hudson,
Ohio: Lexi-Comp, Inc.; February 18, 2016.
Graham, D. Y., & Genta, R. M. (2008). Long Term
Proton Pump Inhibitor Use and Gastrointestinal
Cancer. Current Gastroenterology Reports, 10(6),
543-547.

Yang Y, Lewis JD, Epstein S, Metz DC. Long-
term Proton Pump Inhibitor Therapy and Risk

of Hip Fracture. JAMA.2006;296(24):2947-2953.
doi:10.1001/jama.296.24.2947.

Ito, T., & Jensen, R. T. (2010). Association of Long-
term Proton Pump Inhibitor Therapy with Bone
Fractures and effects on Absorption of Calcium,
Vitamin B12, Iron, and Magnesium. Current
Gastroenterology Reports, 12(6), 448-457. http://
doi.org/10.1007/s11894-010-0141-0

Laurie Buonaccorsi
Anne Copeland Sonia Kim
Sally Doan

Christopher Goldrick

Ahn Hoang

Emory Lin

Cheryl Johnson

Crystal King

14.

15:

Michael Jones

Wolfe, M. M. (2016, February 22). Overview and
comparison of the proton pump inhibitors for the
treatment of acid-related disorders (M. Feldman
& S. Grover, Eds.). Retrieved February 29, 2016,
from https://www-uptodate-com.proxy1.lib.tju.
edu/contents/overview-and-comparison-of-
the-proton-pump-inhibitors-for-the-treatment-
of-acid-related-disorders?source=search_
resultSsearch=proton pump inhibitors
efficacySselectedTitle=1~150.

Lexicomp Online®, Patient Education — Disease
and Procedure, Hudson, Ohio: Lexi-Comp, Inc.;
February 18, 2016.

Blank, M-L., Parkin, L., Paul, C., & Herbison, P.
(2014). A nationwide nested case-control study
indicates an increased risk of acute interstitial
nephritis with proton pump inhibitor use.
Kidney International, 86(4), 837-844. http://doi.
org/10.1038/ki.2014.74

Proton Pump Inhibitors. Drug Facts and
Comparisons. Facts & Comparisons [database
online]. St. Louis, MO: Wolters Kluwer Health, Inc;
2016. Accessed June 14, 2016.

Anna Oakes-Riley
Zachary Oleszczuk
Sandeep Saini

Jordan Strieter

Christina Marrongelli
Ashlee Mattingly

THANK YOU TO OUR 2016 CORPORATE SPONSORS

Boehringer Ingelheim
McKesson Corporation
Pharmacists Mutual Companies

Pharmacy Technician Certification Board
22 MARYLAND PHARMACIST | SUMMER 2016

Care Pharmacies
PharmCon/FreeCE.com

Rite Aid

CE Questions

Which of the following best describes the mechanism of 6 Which of the following variables has been shown to

action of proton pump inhibitors? increase the risk of hip fracture with long-term PPI
A. Float on top of gastric contents, which are less toxic therapy?
when stomach content is refluxed A. Longer durations of therapy
B. Blocks the histamine-2 receptors B. Patient age
C. Irreversibly inhibiting the H+/K+ ATPase pump on C. Patients receiving a bisphosphonate
parietal cell D. Patients with low potassium

D. Stimulated sodium bicarbonate secretion from
mucosal cells

7 JRisa 72 year old man who has been taking a PPI for 4
years. Which of the following best describes symptoms

2 Which of the following is NOT an indication of one of suggestive of hypomagnesemia?
the proton pump inhibitors? A. Tetany, seizures, cardiac arrhythmias
A. Healing erosive esophagitis B. Muscle weakness, muscle spasms and tachycardia
B. Risk reduction for NSAID-induced gastric ulcerations C. Increased thirst, delirium and nausea
C. Part of a multidrug regimen for Clostridium difficile D. Increase thirst, increased hunger and increased
infection urination

D. Short term treatment of duodenal ulcer

8 The development of acute interstitial nephritis (AIN) due

3 If Vitamin Bl2 deficiency develops subsequent to PPI to PPI therapy is associated with which of the following
therapy, when is this most likely to occur? variables?
A. Within the first month of therapy A. PPI dosage
B. Within the first 3 months of therapy B. Patient age
C. Within the first year of therapy C. Patient gender

D. Generally, after at least 2 years of therapy D. None of the above

Which of the following increase the risk of PPI-induced Which of the following is the indication for Prevpac?

Clostridium difficile infection? A. Active benign gastric ulcer

A. Patients who are chronically ill B. Heartburn

B. Immunosuppressed patients C. H. pylori eradication

C. Patients who have received antibiotic therapy D. NSAID associated gastric ulcer prophylaxis
D. AandB

10 Which of the following PPIs is available as a parenteral

E. A,BandC formulation?
5 True or False: Although the risk of developing A. Esomeprazole
gastrointestinal cancer from PPI therapy is very low, B. Pantoprazole
particularly in the absence of H. pylori infection, long- C. Rabeprazole
term PPI inhibitor use in the presence of H. pylori is D. AandB
associated with gastric inflammation and development E. ABandc
of atrophy. Answers on page 21
A. True

B. False

Save the Dates

G9O0QOO0C0

Board of Trustees Mtg. Pharmacists Month Board of Trustees MPhA Holiday Party Board of Trustees MPhA 2017 Mid-Year Maryland Pharmacy

September 15 Medication Errors CE Meeting December 15 Meeting Meeting — DoubleTree Coalition Legislative
Sponsorship and in cooperation with November 17 January 19. 2017 Hilton, Columbia, MD Day — Annapolis, MD
presentation by the U.S. Food February 12, 2017 February 16, 2017

AstraZeneca - and Drug

SGLT-2 Inhibition: A Administration

Glucuretic Treatment October 27

coun heee, All activities held at MPhA Headquarters unless otherwise noted.
Diabetes

Visit www.marylandpharmacist.org to register online or for more information.

MARYLANDPHARMACIST.ORG 23

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The New Normal
DSCSA Compliance Tips: Policy Matters

What is my new normal? The newly enforced Food and Drug Administration's (FDA)

Drug Supply Chain and Security Act (DSCSA) requires electronic tracking and tracing of all
dispensed prescription drugs and requires a process for product verification in the event of
a suspect product and mandatory reporting requirements. These latest regulations bring a
new way of life and create a new normal when approaching compliance as a part of your
day to day business practices. The best way to document standard operating procedures
related to DSCSA is to adopt and document policies.

Developing your Policy and Procedure Manual for DSCSA
compliance may seem like a daunting task, especially
when considering all of the elements of the new law
and what is required of you as a dispenser. A store policy
clearly communicates to staff the standard operating
procedures for any process, ensuring that all employees
handle situations consistently. Adopting a policy is also
an important risk management move because, if done
properly, it verifies your standard business practices.
Even if an employee makes mistakes, evidence of a clear
policy and guidelines (which the employee may not
have followed) will be helpful to lessen any potential
fines or penalties. A clear policy combined with annual
staff training is excellent protocol to show compliance
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InfiniTrak, has been following the development of
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; When designing a software solution, they looked at the

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Keeping a policy up to date and easily independent pharmacies like yours, and created a tool

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InfiniTrak is a cost-effective, easy to use software that
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YLANDPHARMACIST.ORG 25

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Helping You Care For Your Community

What a great 134"
Convention!

Members from all over the
state gathered in Ocean City,
MD to learn, network and
celebrate professional and
community achievements.
This issue is a wonderful visual
recap of those balmy days.
While we had great fun and
learned quite a bit, the House
of Delegates also kept us
relevant by passing two timely
resolutions on medication
affordability and the
pharmacists role in naloxone.

We have so many pharmacists and student pharmacists who
are working hard in their day jobs, while also giving back to
the profession via mentoring and volunteering within MPhA
and their own communities. It was truly an honor to recognize
them during the Excellence in Pharmacy Awards Luncheon.
Thank you to all our attendees, presenters, sponsors,
contributors and exhibitors for your participation in the 134th
Convention.

We are already preparing for the 2017 meetings and looking
for your input. Are you doing something new and innovative
in your practice setting? We'd love to get you on the program.

io Buy-Sellapharmacy.com’

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Executive Director’s Message

Please consider responding to our call for abstracts at www.
marylandpharmacists.org.

Kudos to our new PharmDs! I have enjoyed getting to know
many of the students and attending their celebratory banquets
this past Spring. Their education and experiences continue

to pave the way for advances in pharmacy practice and our
push to achieve provider status. Let us continue to fight for

all pharmacists to practice at the top of their training and
education!

Since the last publication, we've completed meetings

with President of the Senate Mike Miller, members of the
General Assembly, as well as with the office of the Insurance
Commissioner and Maryland's Attorney General Brian Frosh.
We are laying the groundwork for a powerful 2017 legislative
session!

Please continue to share your thoughts and ideas with your
MPhA leadership and heed our calls to action. Your combined
voices provide a chorus that is hard to ignore!

Enjoy the rest of your summer! @

Aliyah N. Horton, CAE
Executive Director

Your Local Specialist

Jim Beatty, R.Ph.
jimb@buy-sellapharmacy.com
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MARYLANDPHARMACIST.ORG 27

Do you know a pharmacy technician
ready to take on more responsibility
in the pharmacy?

The University of Maryland School of Pharmacy’s new, online PharmTechx
Program will elevate a technician’s abilities and improve the efficiency of
your pharmacy.

The PharmTechX Program at At the end of the program, technicians will be able to:
the University of Maryland e Assist with medication management and storage
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Your Membership
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Now is the time to renew your
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ELE EN

FALL 2016

ISSION-FOCUSED;

STRENGTHEN

ANNUAL CONVENTION
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ARYLAND;
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SST. ye6? MARYLAND PHARMACISTS ASSOCIATION

ARYL.
Ave
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Nonwise”

MPhA OFFICERS 2016-2017

Hoai-An Truong, PharmD, MPH, FNAP,
Chairman

Kristen Fink, PharmD, BCPS, CDE,
President

Cherokee Layson-Wolf, PharmD, CGP.
BCACP, FAPhA, Vice President

Matthew Shimoda, PharmD, Treasurer

David Sharp, PhD, Honorary President

HOUSE OFFICERS

Ashley Moody, PharmD, BCACP, AE-C,
Speaker

Richard Debenedetto, PharmD, MS,
AAHIVP, Vice Speaker

MPhA TRUSTEES

Mark Ey, RPh, 2017

G. Lawrence Hogue, BSPharm, PD, 2017

Wayne VanWie, RPh, 2018

Chai Wang, PharmD, BCPS, AE-C, 2018

Amy Nathanson, PharmD, BCACP, AE-C,
2019

Darci Eubank, PharmD, 2019

Rachel Lumish, ASP Student President
University of Maryland School of
Pharmacy

EX-OFFICIO TRUSTEES

Rondall Allen, PharmD, Dean
University of Maryland Eastern Shore
School of Pharmacy

Natalie Eddington, PhD, Dean
University of Maryland School of
Pharmacy

Anne Lin, PharmD, Dean
Notre Dame of Maryland University
School of Pharmacy

Mayrim Millan Barrea, ASP
Student President
Notre Dame of Maryland University
School of Pharmacy

Tolani Adebanjo, ASP Student President
University of Maryland Eastern Shore
School of Pharmacy

Paul R. Holly, PD, MPhA Foundation

PEER REVIEWERS

W. Chris Charles, PharmD, BCPS, AE-C

Caitlin Corker-Relph, MA, PharmD
Candidate 2017

LCDR Mathilda Fienkeng, PharmD, RAC

Nicole Groves, PharmD

G. Lawrence Hogue, BSPharm, PD

Edward Knapp, PharmD, PhD

Frank Nice, RPh, DPA, CPHP

Hanna Salehi, PharmD, MLS

STAFF

Aliyah N. Horton, CAE, Executive
Director

Shawn Collins, Membership Services
Coordinator

Carole Miller, Operations and Program
Associate

CONTRIBUTORS
Virginia Nguyen, PharmD
Shelby Holstein, CPhT
Jennifer Thomas, PharmD

Maryland Pharmacists Association,
9115 Guilford Road, Suite

200, Columbia, MD 21046,

call 443.583.8000, or

email aliyah.horton@mdpha.com.

Special thanks to Graphtech, Advertising
Sales and Design

President’s Pad

Dear Pharmacy Community,

Hello Everyone! I hope you are having a wonderful Fall and
are enjoying the excitement of Pharmacy month! There are
many wonderful events taking place to promote pharmacy
and our role in quality patient care. There are events focused
on professional development to help propel us to the next
level of excellence in our careers and events focused solely
on celebrating our integral part of the communities we serve.
If you have not yet participated in any of these events -
please let me » encourage you to join us! Too busy this month? It is ok! We have many
opportunities each and every month to get involved - as much, or as little, as you
would like.

I was recently asked why I am so passionate about the Maryland Pharmacists
Association (MPhA). How can I explain what MPhA means to me? For me, the first
time I walked into one of the monthly meetings, I felt that I had found a place where I
could make a difference and my contributions would be appreciated. The members of
this pharmacy family all have a common goal of making our profession the best it can
be. Our members are approachable, friendly and upbeat. They can serve as sounding
boards, voices of encouragement, voices of experience and sometimes of reason.
They want to collaborate and bounce around ideas, and I often find that several of

us in a room tend to build upon each other and take an idea to the next level. They
inspire me to do more, and I walk away from our meetings energized and excited to
be a part of our profession. As an association, we are looking to the future, imagining
endless possibilities and doing our best to pave the way to make them a reality.

Our mission is to strengthen the profession of pharmacy, advocate for all Maryland
pharmacists, and promote excellence in pharmacy practice. No one person has to do
it all, because as a group, we unite our skills, passions, and interests to form a strong
unified voice.

We need you. We need you to join, be active, and participate in the meetings.
Volunteer for a committee or event. Share what you are hearing in the community.
Share what you would like to see happen or what resources and opportunities you
are looking for. Share best practices or challenges. Share your expertise. Share ideas.
Share your excitement. Meet others in our profession who want to do the same. By
interacting with our colleagues, socially and professionally, we learn from each other
and become more interconnected and knowledgeable, allowing us to strengthen our
profession and better serve our patients.

Our meetings and convention committee, professional development committee, new
practitioner network and technician network are working hard to develop numerous
opportunities and events for us to participate in and take advantage of throughout
the year. From CE programming to community service opportunities, we are ready to
meet your needs. | look forward to hearing from you and seeing you there! @

Sincerely,

UKs Wh, Beir
Kristen Fink
President

Cover Story

YOUR MEMBERSHIP MATTERS
- RENEW TODAY NEW PAYMENT

OPTION!

Online payment now allows for dues
to be paid in a two-part installment

e Advocacy — MPhA is your voice for legislative and regulatory plat

matters. With your input, MPhA collaborates with elected leaders
and other Maryland pharmacy stakeholders to impact pharmacy MPHA MEMBER
practice and the public’s health. Members engage in the Annual SERVICE PARTNERS

Legislative Day and provide MPhA testimony in Annapolis.
fad ; MPhA-specific links and additional
Continuing Education and Professional Development — MPhA information to these partners can be

offers diverse live CE to ensure you meet your license and found on the MPhA Resources Page.
certification requirements; and have the tools and resources to Credible

support your professional development. Plan to attend the Mid- Student-loan refinancing

Year Meeting, Annual Convention and bi-monthly CE events on (415) 456-7634

clinical and policy topics.

Edelman Financial
e Communications — MPhA is your resource for the latest news Edelmanfinancial.com
in the pharmacy industry, around the State, and the Maryland Financial Planning
pharmacy community. Through the quarterly journal, Maryland (888) PLAN-RIC
Pharmacist, e-newsletter, Monday Message, and social media InfiniTrak
(Twitter, Facebook) MPhA keeps you connected and informed. Infinitrak.us

Track and trace compliance software
(844) 464-4641

Professional Recognition — MPhA serves as portal for
nominations to serve on Maryland state pharmacy and healthcare
boards, commissions and task forces. In addition, MPhA offers Pharmacists Mutual Companies
peer recognition via annual professional practice, community phmic.com

: Insurance products and services
1 C WELL a f
a eee innovation awards as well as scholarships for (202) 429 7423
U ;

Pharmacy Quality Commitment
pqc.net
Quality assurance compliance

Networking — MPhA is excited to have completed a full year in
our new home in Columbia, MD. We are more centrally located

in the state and offer you a fantastic space to learn, network resources
and advance pharmacy with your colleagues. In addition, our (866) 365 7472
member networks provide opportunities for N ew Practitioners, Pharmacy Technician
Pharmacy Technicians and Federal Pharmacists to engage on Certification Board
issues specific to their needs and careers. Ptcb.org
Now is the time to renew your membership. Stay a part of MPhA as ad a Technician Certification
the only state-wide professional society representing all practicing (800) 363-8012
pharmacists, pharmacy technicians and student pharmacists. Please
renew your membership by logging into your online account at Tickets-at-Work

Ticketsatwork.com
Discounts on theme parks, attractions
and shows

www.marylandpharmacist.org. If you have any questions, please call
the office at 443-583-8000. Membership matters! @

MARYLANDPHARMACIST.ORG 5

What has MPhA been doing?
Member Mentions highlighted below!

Left to right: Hoai-An Truong, Yen Dang, Magaly Rodriguez de Bittner, and
Kyle Melin attended and presented at the International Pharmaceutical
Federation (FIP) 76th World Congress of Pharmacy and Pharmaceutical
Sciences 2016 in Buenos Aires, Argentina, August 28-September 1 with the
theme: “Rising to the Challenge: Reducing the Global Burden of Disease.”

Tom Menighan MBA, ScD Named as Vice President to
FIP Board

MPhA Member and American Pharmacists Association CEO
Tom Menighan has been named as one of the nine vice
presidents to the International Pharmaceutical Federation
(FIP). Tom most recently served as the 2015-2016 Honorary
President of MPhA.

Toyin Tofade, PharmD, MS, BCPS, CPCC is the New Dean
of the College of Pharmacy at Howard University

Toyin started her tenure as the new Dean of the College of
Pharmacy at Howard University this past August. As Dean,

Dr. Tofade will provide direction and leadership, vision and
oversight for the College of Pharmacy, reporting to Provost
and Chief Academic Officer, Dr. Anthony Wutoh. Dr. Tofade
most recently held the position of Assistant Dean and
Associate Professor at the University of Maryland School of
Pharmacy. She has also served on the faculty of the University
of North Carolina at Chapel Hill School of Pharmacy.

Dr. Tofade earned her Bachelor of Pharmacy degree at
Obafemi University in Nigeria, and her Master of Science in
pharmacy practice and Doctor of Pharmacy, (Pharm D) from
the University of North Carolina at Chapel Hill.

Dixie Leikach, RPh, MBA Finalist in Next Generation
Pharmacist Awards

Pharmacy Times and Parata systems announced that Dixie
Leikach was a finalist in the Civic Leader Category of the Next
Generation Pharmacist Awards. Nominations were based on
adherence to professional standards, experience as it related
to the category and advancement of the profession. Finalists
were selected across industry practice settings and were
recognized at an awards gala in Boston in August.

6 MARYLAND PHARMACIST | FALL 2016

Nicole Brandt, PharmD, MBA BCPP, CGP, FASCP has
been named the new Executive Director of the Peter Lamy
Center on Drug Therapy and Aging at the University of
Maryland School of Pharmacy.

Please remember to submit your member mentions to
MPhA. Let us all celebrate your personal and professional
achievements. Send your updates to admin@mdpha.com.

In Memoriam - Ronald A. Sanford BSP 1944- 2016
Ron Sanford is remembered as a steadfast
and active member of the Maryland
Pharmacists Association (MPhA). He served
as President in 1984 and also as treasurer
during his long and active engagement in
the organization. His long-time service to
MPhA also earned him the Henry Seidman
Distinguished Achievement Service Award
in 1994. The award recognizes an individual
who has made major contributions to MPhA,
organized pharmacy and the profession of pharmacy. He
was instrumental in changing the name from the Maryland
Pharmaceutical Association to its present one.

Ron was a fixture with his son, past President Mark Sanford,

at the MPhA Annual Convention, its House of Delegates and
Crab Feast held at the Berlin Fire Hall. Many remember him
as being the first to begin eating crabs and the last to finish as
the volunteer firemen cleaned the entire hall around him.

He also served as President of the University of Maryland
School of Pharmacy Alumni Association and later for many
years as its treasurer. He loved crunching numbers. Ron
received the Honored Alumnus Award from the Alumni
Association, is on the Honor Roll of the Life Members of that
organization, and was a David Stewart Associate.

Ron was a member of the Wedgewood Club, a group of
pharmacy associates and friends, who met every third
Thursday of the month for a few drinks, dinner and laughs.
Even when Ron was unable to drive, his wife Betty would
drive him there and have dinner in another part of the
restaurant so that Ron could maintain the friendships that had
developed over the years.

Ron was devoted to his chosen profession. But above all, he
was devoted to his family. Ron was “a loving husband and
father who lived life on his own terms and enjoyed it to the
fullest" said Betty. He was proud of Mark's accomplishments
following his career in Pharmacy, and of Valerie for her career
in Nursing. He loved the ocean where he and Mark had a
condo called "Sanford & Son.” He loved his family and his cat.
His theme song was an old Frank Sinatra tune — "I Did It My
Way" — and he did.

Modified from an original statement by friend and colleague
George C. Voxakis, PharmD

New Practitioner Network and MPhA Foundation
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“aa 6 4\

The New Practitioner Network (NPN) held a social and
fundraising event to support the MPhA Foundation.
Partnering with the Baltimore Orioles, NPN participated in
the OriolesREACH High-Five Fundraising Program, a unique
fundraising effort allowing for $5 of each Orioles ticket
sold to be donated to a non-profit organization of their
choice. As a way to welcome new practitioners in the area
and introduce them to MPhA, NPN hosted a meet-and-
greet social at Pratt Street Alehouse before heading over
to Camden Yards to see the Baltimore Onioles take on the
Washington Nationals in a “Battle of the Beltways.” Overall,
the fundraiser raised funds for the MPhA Foundation and

attendees witnessed an Orioles win (better luck next time
Nats!)

Technician Networking Social

The newly formed Pharmacy Technicians Network hosted
its inaugural event at MPhA headquarters. The networking
social gathered pharmacy technicians from varied practice
settings and lengths of practice—attendees included
technicians with less than one year of experience to more
than 29 years. Chaired by Shelby Holstein and Andrew

Wherley, the attendees participated in focus groups and

: o> 4 —— P
Co-chairs Shelby Holstein and Andrew Wherley welcome attendees

Working groups brainstorm pharmacy technician needs in MD

fun. The Mid-Year Meeting will feature a Technician Track
with content based on feedback from the focus groups
Five CE were given away in a contest from PharmTechx,
the Advanced Pharmacy Technician Training Program

at University of Maryland, Baltimore and materials were
distributed about the Pharmacy Technician Certification

Program, sponsored by the Pharmacy Technician
Certification Board.

(As reminder to Pharmacists and Pharmacy Technicians. \
The nominations for the 2017 MPhA Pharmacy
| Technician of the Year Award are open. Nominations

may be submitted via the www.marylandpharmacist.

org Membership > MPhA Pharmacy Technician Award.

| The award will be given at the 2017 Mid-Year Meeting on
\ February 12, in Columbia, MD. Deadline December 8, 2016

Fall Board Meeting

The September board meeting and MPhA kick-off was
standing room only! Kristen Fink was formally installed

as the 2016-2017 President by Past Chairman Dixie

Leikach. Dixie also presented her with the NCPA Pharmacy
Leadership Award. The meeting was sponsored by Astra
Zeneca and included a presentation by Dr. Daniel Gozzi,
Endocrinologist with the Adventist Medical Group. Updates
from each Board of Trustees meeting are included in the first
Monday Message following the meeting

MARYLANDPHARMACIST.ORG 7

Capitol Hill Health Fair

Monique Spears and Dipen
Patel giving Rep. Carter a body
composition test

Rachel Lumish overseeing a bone
density test with staff from Rep.
John Sarbanes’ (D-MD) Office

Rep. Carter with Aliyah N. Horton,
CAE, MPhA Executive Director

Tolani Adebanjo ensuring
documentation is correct for
cholesterol and glucose testing

On September 22, American Pharmacists Association
(AphA) hosted its 4th Annual Capitol Hill Health Fair.
APhA partnered with the office of Rep. Buddy Carter
(R-GA), National Association of Chain Drug Stores,
National Community Pharmacists Association, the
American Society of Health-System Pharmacists and
Walgreens to host the event. Student pharmacists from
University of Maryland School of Pharmacy, Notre
Dame of Maryland University School of Pharmacy and
the University of Maryland Eastern Shore School of
Pharmacy, as well as schools from Washington DC and
Virginia, participated by registering attendees; providing
body composition, bone density, blood pressure,
cholesterol and glucose screenings; and administering
flu shots. MPhA APhA-ASP Student Trustees Rachel
Lumish (UMB) and Tolani Adebanjo (UMES) were on
site. MPhA's Executive Director had the opportunity to
thank Rep. Carter, the only pharmacist in Congress, for
his advocacy on behalf of the pharmacy community.

MPhA’s Pilot Initiative for “FULL” CRISP Portal
Access for Community Pharmacists Set to Launch
Today, through the Chesapeake Regional Information
System for Our Patients (CRISP) portal, pharmacists are
provided with access to Prescription Drug Monitoring
Program (PDMP) data. The role of the community

8 MARYLAND PHARMACIST | FALL 2016

pharmacist has expanded significantly over recent
decades; community pharmacists require greater
access to clinical information to support care delivery.
Access to clinical information beyond PDMP data could,
among other things, enable community pharmacists to
1) properly assess controlled substance use 2) enhance
medication reconciliation in community pharmacy
settings, 3) optimize medication management for
chronic conditions, 4) assist patient care coordination
and 5) mitigate medication related harm.

The MPhA Pharmacy HIE Access Workgroup, chaired
by Jennifer Thomas, was convened to develop
recommendations for implementing a limited use case
pilot that will inform efforts to expand CRISP services
to all community pharmacies. Eight (8) pharmacies
have signed on to participate in the pilot initiative:
Catonsville Pharmacy, Finksburg Pharmacy, Grubbs
Pharmacy, Halethorpe Pharmacy, Independent Drug,
Jarrettsville Pharmacy, Sharpsburg Pharmacy and
Whitesell Pharmacy. The pilot is scheduled to launch
October 2016. Stay tuned for updates on this project
and pharmacist access to the “full” CRISP portal.

Improving Transparency and Accuracy in Medicare
Part D Spending Act

National Community Pharmacists Association

(NCPA) hosted a roundtable discussion and meeting
with Rep. John Sarbanes (D-MD) to discuss the

needs and concerns of community pharmacy. The
group discussed the bill HR 5951/S3308, Improving
Transparency and Accuracy in Medicare Part D
Spending Act that was set to be introduced. Sponsored
by Rep. Griffith Morgan (R-VA) in the House and
Senator Shelly Moore Capito (R-WV) in the Senate,

the bill amends XVIII of the Social Security Act to
prohibit prescription drug plan sponsors and MA-

PD organizations under the Medicare program from
retroactively reducing payment on clean claims
submitted by pharmacies. The bill is intended to
improve PBM transparency and ban retroactive DIR fees.
MPhA has expressed support for the bill. Rep. Sarbanes
has signed on as a cosponsor of the bill. Send a note to
thank him.

From L-R: Mark Ey (MPhA Trustee); George Garmer; Mike Wysong; Rep.
Sarbanes; Mike Tomberlin of NCPA; and Aliyah Horton

Tips to Save on Your Student Debt

By: Stephen Dash, CEO, Credible

Many graduates put off refinancing their student loans simply because

they dontt understand the process, but the average graduate student leaves
school with loans totaling over $30,000. MPhA has partnered with Credible
to help our members better understand and save on their student debt. The
following ts a list of common misconceptions debunked.

. You are stuck with your loans
when you graduate

Many graduates refinance their
federal and private student loans

Inquires made during a focused
time period (for example 30 days)
have little to no impact on your
score.

after graduation because, under
certain circumstances, refinancing
can result in lower interest rates,
lower monthly repayments, and
significant savings.

Overall, there is a great deal of
misinformation available about
student loans, causing a general

lack of understanding. Credible
enables MPhA members to compare
refinancing offers from multiple
lenders side-by-side, and choose the
offer that's best for them. To learn
more about student loan refinancing,
visit Credible on the MPhA Partner
Resources Page. @

2. Every lender offers similar rates
Depending on the lender, interest
rates on student loan refinancing
products can range from under 2%
to well over 8.0%.

interest if you are able to decrease

‘ your rate.
3. Increasing the term of your

loan always results in paying
more interest

Increasing the term of your loan
can still result in less overall

4. Shopping around for the best
rate will hurt your credit profile
The credit bureaus treat “rate
shopping’ as a single credit pull.

Have you Checked Out MPhA’s Career Center?

MPhA‘s Career Center is designed to connect talent with opportunity. The career center is the far right button on the
MPhA Website. Job seekers can post their resumes and search through job postings as well as set up job alerts, so
that available jobs find you! The career center also features a career resources section. The career resources provide
everything you need to make your resume stand out, prepare for and ace an interview, advance your career and
navigate the job market in the digital age by making sure your social media presence and digital communication
styles are working to your advantage.

Once registered in the site, you will have access to the “Ask the Experts” features which gives you the ability to submit
a question to a team of trained Coaching Experts. These experts have been working with job seekers including
people in career and life transitions for the last twenty years. They are here to answer your questions on refining
your resume, preparing for an interview, guiding you through your job research, networking, negotiating or assisting
with any other aspect of your job search or career shift.

Employers can customize packages for job notice distributions and for access to resumes posted by job seekers. Visit
www.marylandpharmacist.org @

MARYLANDPHARMACIST.ORG 9

DON'T MISS THIS MEETING

REGISTRATION IS OPEN
Register Online at
www.marylandpharmacist.org

Up to 6 CE for both Pharmacists
and Pharmacy Technicians

Ol for a day of live continuing
Registration/

eas education, networking, Datla 8
Continental Breakfast: House of Delegates and Hilton Columbia
8:00 am — 8:30 am a AWara Diccontation 5485 Twin Knolls Rd.
Columbia, MD 21045

Program:
8:30 am — 5:30 pm

Become Engaged

As a member of MPhA, you join a dynamic, interactive group of pharmacists, student
pharmacists and pharmacy technicians who are dedicated to improving the health and
well-being of Maryland residents. Connect and get involved in a number of committees,
from staying on top of important pharmacy legislation on the Advocacy Committee, to
reviewing and providing content for the Maryland Pharmacist, identifying content and
speakers for MPhA's Mid-Year Meeting and Annual Convention, or creating pathways for new
opportunities via the Health Information Exchange and Technology Task Force to dozens of
other opportunities to volunteer...there is a place for you on an MPhA Committee!

If you are interested in joining one of the Committees or Task Forces or have any questions, please e-mail
the Committee Chair. For committee positions appointed by the MPhA President, please contact 2016-2017

President Kristen Fink at finkkristen@gmail.com.

COMMITTEES

Advocacy Committee: serves as an advisory body

to Board of Trustees on legislative and regulatory
and/other matters that may impact the practice of
pharmacy in Maryland. The committee is responsible
for reviewing legislative and regulatory proposals;
recommending legislative and regulatory priorities to
the Board of Trustees; advising on the implementation
of any MPhA policies that require legislative action;
and representing MPhA on the Maryland Pharmacy
Coalition Legislative Committee. The Committee may
also work with the Executive Director on specific bills
in the Maryland General Assembly.

Chair: Chai Wang, chaifu.;wang@gmail.com

Budget and Finance Committee: prepares the
proposed annual budget for the Association and
presents to the Board of Trustees for approval at least
two months prior to the beginning of the fiscal year.
The Committee also monitors Association investments
to ensure compliance with the Investment Policy
Statement.

Chair: Matt Shimoda, drmgshimoda@aol.com

Building Committee: The Treasurer serves as the
chair of the building committee which consists of
the following persons: Chair of the Board of Trustees,
Vice President, Treasurer and two at-large members
appointed by the MPhA President. The Committee
oversees the financial condition of EFK Properties,
LLC and the management of property(ies) owned by
EFK Properties, LLC. The Committee reports at least
quarterly to the MPhA Board of Trustees

Chair: Matt Shimoda, drmgshimoda@aol.com

Communication Committee: assists staff in telling
the MPhA story by promoting and featuring the
Association's activities and members. The committee
serves in an advisory capacity to identify relevant
content for MPhA’s digital, social and print media,
including our quarterly journal, Maryland Pharmacist.
The Committee works with staff in identifying
subject matter experts; engaging members via social
media; and collaborating with other committees to
supplement marketing of MPhA meetings and events.

Co-chairs: Deanna Tran and Bonnie Li-MacDonald

E-mail: tran.deanna@gmail.com and
bonnie.x.limacdonald@gmail.com

Constitution and Bylaws Committee: responsible
for reviewing the current bylaws and soliciting
membership for proposed changes. These
recommendations are then submitted to the Board of
Trustees for a board opinion and then presented to
the House of Delegates for a vote as indicated in the
By-Laws.

Chair: Ashley Moody, mccabe.ashley@gmail.com

Meetings Planning Committee: serves as an advisory
body to MPhA staff on the theme, program content
and schedule for MPhA conferences. The committee
works with other MPhA committees to enhance
marketing and engagement opportunities for MPhA
meetings. The committee also assists staff when
needed and acts as a hospitality committee at meeting
sites.

Co-chairs: Darci Eubank and Sadhna Katri

E-mail: deuba0O01@umaryland.edu and
anilsadhna@yahoo.com

MARYLANDPHARMACIST.ORG 11

Membership Committee: comprised of pharmacy
professionals, from varied practice areas, who
volunteer to personally engage current and potential
members of MPhA. The committee serves as a
resource and sounding board to MPhA staff on the
development of membership recruitment, retention
and reclamation strategies and campaigns. The
committee works to increase the value proposition of
MPhA membership.

Chair: Andrew Haines, andrewhaines2@gmail.com

Nominating Committee: responsible for the
presentation of a slate of at least two (2) individuals
for each forthcoming available seat on the Board of
Trustees and the office of Vice President, and Treasurer
(on alternate years) to the House of Delegates at

the Mid-Year Meeting. The Nominating Committee
shall consider geographic diversity, practice specialty,
experience, and the requirements included in the
Association's bylaws in making its nominations.

The slate of candidates is presented to the House of
Delegates at the Mid-Year meeting.

Chair: Cherokee Layson-Wolf,
cwolf@rx.umaryland.edu

Preservation Committee: responsible for advising
MPhA staff on the upkeep, display, and cataloging of
the association's historical pieces. The committee is
also responsible for providing content to showcase
Maryland pharmacy history via MPhA‘s quarterly
journal and website.

Chair: Doug Campbell, dougstoytrucks@aol.com

Cartitie ation
xcellence

Certification Board has certified
over 400,000 pharmacy technicians

nationwide and is the only pharmacy
technician certification program endorsed
by the American Pharmacists Association,
the American Society of Health System
Pharmacists, and the National Association
of Boards of Pharmacy.

www.ptcb.org

Professional Development Committee: responsible
for furthering the professional development, including
continuing education, of MPhA members and
furthering the mission of MPhA in identifying and
developing professional projects to expand awareness
and educate the public about the value and role of
pharmacist services in the healthcare community.

Co-chairs: Amy Nathanson and Virginia Nguyen

E-mail: anathansonrx@gmail.com and
vnguyen@umaryland.edu

Resolutions Committee: required to review all
submitted resolutions prior to the Annual Meeting and
present a report to the Board of Trustees for purposes
of determining the Board's position prior to the second
House of Delegates meeting for vote. The Committee
may also work with members to help formulate
resolutions. The resolutions committee is chaired by
the Vice Speaker of the MPhA House of Delegates.

Chair: Richard DeBenedetto,
radebenedetto@umes.edu

Scholarship Committee: in collaboration with the
MPhA Foundation annually reviews applications and
awards three scholarships to students attending a
school of pharmacy in Maryland.

Chair: Wayne VanWie, wvanwie@comcast.net

NETWORKS

The networks are designed to provide a venue for
ongoing collaboration, networking and socializing.

New Practitioner Network (NPN): is a welcoming
group for practitioners who have
graduated in the past 5 years that eases
the transition into Maryland pharmacy
practice from student to new practitioner
pharmacist. NPN assists young
professional members by developing
resources, learning and volunteering
opportunities relevant to the young
pharmacists today, while building a
community for the next generation of
pharmacists. For more information, visit
the New Practitioner Network webpage.

Co-chairs: Sam Houmes and Lauren
Lakdawala

E-mail: houmes.sam@gmail.com and
llakdaw1@jhmi.edu

Past Presidents Network: is comprised
of Past Presidents Council (PPC). The
group is chaired by the immediate past
president of MPhA. As PPC the group

Pharmacy Technician Certification Board

12 MARYLAND PHARMACIST | FALL 2016

CONNECT ONLINE: Ei ‘in| (3

administers MPhA‘s award process and is
responsible for the promotion of MPhA

awards and selection of recipients. The group may also
recommend nominees for national pharmacy-related
awards. The network will provide an opportunity for
Past Presidents to engage beyond the awards process.

Chair: Dixie Lekach, finksburgrx@gmail.com

Technician Network: To further develop our
technician membership and the purpose and activity
will be determined by those who volunteer to be the
founding members.

Co-chairs: Shelby Holstein and Andrew Wherley

E-mail: shelby2k3@gmail.com and
andrew.wherley@gmail.com

Federal Pharmacists Network: To further develop
our Federal pharmacist membership and identify
membership services and activities geared toward this
cohort.

Co-chairs: Mathilda Fienkeng and Mary Kremzner

Email: mathilda fienkeng@gmail.com and
mary.kremzner@fda.hhs.gov

TASK FORCES

MPhA Task Forces are designed to support a short-
term targeted focus on a specific outcome or initiative.

iO Buy-Sellapharmacy.c com’ |

1- (877)-360-0095
www.buy-sellapharmacy.com

It is a great way to work with colleagues and support
MPhA with shorter investment of time.

Cruise Task Force: responsible for working with

the MPhA staff to investigate and plan of all aspects
of any cruises sponsored by MPhA. This includes
the choice of travel agents, cruise line and itinerary,
continuing education program, and implementation
of all activities on site during the cruise. The cruise
destination shall be determined based on survey
feedback from Membership.

Chair: Arnie Honkofsky and Jim Bresette

E-mail: gobmcarniel@verizon.net and
jlbresette@umes.edu

Health Information Exchange Task Force: Health
Information Exchange and Technology responsible
for working for community pharmacists access

to Maryland's health information exchange, the
Chesapeake Regional Information System for

our Patients (CRISP). Access to CRISP will provide
healthcare information for improved medication
management and services and continuity of care.

Chair: Jennifer Thomas, thomasjena@dfmc.org @

thas ee R. Ph.
jimb@buy-sellapharmacy.com
Tel: 1-(732)-563-0295

Completely Confidential!

Don't Leave Money On The Table
when you transition the ownership of your pharmacy.

* If you are talking with a buyer (particularly a chain buyer), have an offer on the table, haven't

signed anything yet, TALK TO US LAST!!

- If you are contemplating a sale but haven't begun to consider the issues involved, TALK TO

US FIRST!

- Either way, all conversations are TOTALLY CONFIDENTIAL AND TOTALLY WITHOUT OBLIGATION.

THEY COST YOU NOTHING!

Don't be fooled by web sites or advertisements that purport to tell you EXACTLY HOW MUCH you are
leaving on the table. There are no absolutes when selling a business and EVERYTHING is negotiable.

Visit our website to view a list of references that you can contact.

A 15-year track record of successfully completing more than 400 independent pharmacy sales.

MARYLANDPHARMACIST.ORG 13

By 2020 there will be an estimated shortage of 20,400 |

primary care physicians in

practitioners and physician assistants are fully utilized, |
patient needs will not fully be met.

5.9

Million

people?

Maryland's Pharmacists:
Improving People's Health

| Maryland has a shortage of 160 physicians.'

The 6,060 highly trained Maryland pharmacists are

' ready to bridge the gap by providing chronic disease
management and wellness and prevention services.’

the U.S. Even if nurse

of the physicians
needed to
deliver care’

ready to help’

Diabetes

Prevalence of
chronic disease in
Maryland *°

= et) —

52%

of Maryland residents
were vaccinated for

Smoking causes nearly | of every 5

deaths in the U.S. each year.

Pharmacists are qualified and
capable of providing smoking

cessation counseling.

Immunization rates across the U.S.

Diabetes is a complex condition that is often managed by multiple medications.
Pharmacists can optimize care and help patients understand their medications and their

condition in order to improve outcomes and avoid complications. *?

4.9%

Cardiovascular Disease (CVD)

0 — For patients with uncontrolled high blood pressure, waiting even two months to optimize

medications increases the risk of complications, including hospitalizations.
Pharmacists are highly accessible members of the care team who significantly improve blood
pressure control and can provide timely follow-up and monitoring to improve outcomes.”

50% of people with
chronic diseases do

have continued to increase since not take their ie
medicines correctly.

Medications are critical for the treatment

of chronic conditions. Pharmacists can help
patients use them safely and effectively to
cigarettes avoid medication related problems.'4

14 MARYLAND PHARMACIST | FALL 2016

pew” 96,32 1,500,000
annually on prescription medications:

Investing in pharmacists’ services optimizes the use of those prescription medications.
ile iiess Decades of research have proven the value of including pharmacists on healthcare teams.
Improved health outcomes, lower costs, and increased access to care could be a reality for
Maryland residents if pharmacists were fully empowered fo serve as patient care providers.

yee
Healthcare $$ Spent Pharmacists’ counseling and

on Chronic Conditions On average adherence programs can save the
MMI healthcare system
S555 $1,000
pesca la
tac Sa ae 7
Buixaieaiaaien stele | oi
oa ee fe ahead
DIGI GIGI | per patient
MM MGI =
mba baba with pharmacist | :
a ee ee interventions for patients in the-6 months following
= Go Conditions " with chronic conditions. °* the start of ag new
er

prescription medication.”

On average, a Maryland spends

single hospital 18.2% of its
readmission in the General Fund
U.S. costs $11,200 Expenditures on

with a 21.2% Medicaid. °

readmission rate.”

Pharmacists in Ohio
delivered a 4.4:] RO!

; when providing & O
when pharmacists atlanta teen 4 4

provide clinical Services management services sayed per $1 spent
after discharge. to Medicaid patients. on pharmacists’
Maryland pharmacists services

could do this too! ”

Fe are

more likely to
stay out of the
hospital

This information was developed through a collaboration between APhA and NASPA with
generous support from the Community Pharmacy Foundation.

APhA

References available at www.pharmacistsprovidecare.com

MARYLANDPHARMACIST.ORG 15

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CardinalHealth

Essential to care™

Continuing Ed

Treating opioid-induced
constipation:

A community pharmacy perspective

Christine Nkobena, PharmD Candidate 2019

Leah Sera, PharmD, BCPS
Associate Professor, Department of Pharmacy Practice and Science
University of Maryland School of Pharmacy

Learning Objectives

After reading this article, the learner will be able to:

Key Words
1. Describe the pathophysiology of opioid-induced constipation * Opioid-induced constipation (OIC)
(OIC). e Stimulant laxatives

2. Describe the mechanism of action, adverse effects, and ¢ Osmotic laxatives

contraindications for drugs and drug classes used to treat opioid Peripherally-acting mu opioid
induced constipation. antagonists, PAMORAs

3. Given a patient case, choose an appropriate treatment option for Pain management
OIC based on patient- and agent-related variables.

Palliative care

Introduction

Chronic pain is a significant problem in the United States (US) that affects 100 million people, more than the
combined number of patients with diabetes, coronary heart disease, stroke, and cancer.’* Opioids are commonly
used to treat chronic cancer-related pain and chronic non-cancer pain (CNCP), with approximately 250 million
prescriptions written annually in the US.2 Constipation is one of the most common side effects of opioid-use,
affecting 15-90% of patients with CNCP and up to 90% of patients with cancer pain.*° The discomfort from opioid-
induced constipation (OIC) may lead to discontinuation of opioids and consequently to increased pain.®

OIC, also called opioid-induced bowel dysfunction, has been defined as “a change, when initiating opioid therapy,
from baseline bowel habits, defecation patterns, and what individuals consider normal that is characterized by
any of the following: (1) reduced frequency of spontaneous bowel movements, (2) developing or worsening of
straining to pass bowel movements; (3) a sense of incomplete rectal evacuation; or (4) harder stool consistency.””
Opioid receptors are located throughout the central nervous system and periphery, with the enteric nervous
system in the gut housing the largest concentration of receptors outside the brain.’ Opioids bind with mu-
receptors in the gastrointestinal (GI) tract and interfere with normal GI function by decreasing peristalsis, inhibiting
fluid secretion into the gut, and increasing transit time, which leads to greater absorption of fluid and the
development of hard, dry stools.*? The purpose of this article is to review therapeutic options available for the
prevention and treatment of OIC.

First Line Treatments

Patients starting on opioid therapy should simultaneously begin laxative therapy to prevent, if possible, the
development of OIC. Stimulant laxatives, osmotic laxatives, and stool softeners have traditionally been first line
treatments for OIC. Common stimulant laxatives used in the United States include senna, an anthraquinone

MARYLANDPHARMACIST.ORG 17

glycoside, and bisacodyl, a diphenylmethane.°* These
medications directly stimulate the intestinal mucosa
to increase peristalsis, and soften stool by altering

fluid and electrolyte secretion.’ Osmotic laxatives
commonly used in the treatment of OIC include
polyethylene glycol, lactulose, and magnesium salts
(e.g., magnesium hydroxide), and act by increasing
fecal water content and stimulating peristalsis

via distention of the bowel. Refer to Table 1 for
prescribing information for first line treatment.

Docusate, which softens stool by facilitating the
incorporation of water and fat, has historically

been added to bowel regimens in the treatment of
constipation. It is unlikely to be useful in the treatment
of OIC as monotherapy, as it does not directly address
the pathophysiology of this condition.“ Additionally, a
recent clinical trial has called into question the addition
of docusate to stimulant laxatives in the treatment of
OIC. In this trial, hospice patients were randomized

to receive senna twice daily plus either docusate or
placebo twice daily. No significant between-group
difference was found in stool frequency, volume,
consistency, or in completeness or difficulty of
evacuation.

Common non-pharmacological interventions for the
treatment of constipation include increasing fluid and
fiber intake, and increasing mobility.’* Evidence for the
use of non-pharmacologic treatments in functional
constipation is conflicting, and there is minimal data
regarding the use of these interventions specifically

in OIC.* Like stool softeners, these interventions

do not address the underlying causes of OIC. Some
interventions, such as bulk forming agents (e.g.,
psyllium) may actually be harmful in patients with OIC,

Sidebar Case

Prescribing Considerations

Mrs. Smith is a 54-year old woman with low back pain resulting from a motor vehicle collision two years ago. She is well known

since reduced motility prevents movement of bulked
up stool and can lead to bowel obstruction."

Newer Agents

Patients who fail to respond to a regimen of first line
agents may require targeted therapy. There has been
a great deal of interest over the past several years

in developing agents which specifically address the
actions of opioids in the gut that are responsible for
the development of OIC. Methylnaltrexone bromide,

a peripheral mu opioid antagonist (PAMORA), was
approved in 2008 for the management of OIC in
patients with advanced illness and later approved

for subcutaneous use in patients taking opioids for
CNCP. A double-blind study of patients with advanced
illness (e.g., cancer, cardiovascular disease, pulmonary
disease) found that more patients had a bowel
movement within 4 hours of administration when
treated with subcutaneous methylnaltrexone 0.15 mg/
kg or 0.3 mg/kg than those treated with placebo (62%
and 58%, respectively, vs 14%, P<0.001).”” Similarly,
more patients with CNCP had a bowel movement
within 4 hours when treated with methylnaltrexone
12 mg daily or every other day than those treated with
placebo (34.2% in both groups vs. 9.9%, P<0.001). In
July 2016, the FDA approved an oral formulation of
methylnaltrexone. Methylnaltrexone, which contains
a quaternary amine and is therefore unable to cross
the blood-brain barrier, is active only in the periphery
and therefore does not reverse centrally mediated
analgesia.’ See Table 2 for dosing, precautions, and
side effects of methylnaltrexone and newer agents.

Naloxegol was approved in 2014 for the treatment of
OIC in patients with CNCP. This drug is a pegylated

to your practice. Her primary care physician had been managing her pain with a combination of NSAIDs and acetaminophen.
She tried spinal manipulation and physical therapy, however her pain persisted and she underwent spinal surgery four
months ago. Initially she experienced some symptom relief, but when the pain worsened she began seeing a pain specialist
who prescribed controlled-release oxycodone about a month ago. She returns to the pharmacy today and asks, “What do you
recommend for constipation?” Her past medical history includes hypertension, type 2 diabetes, chronic low back pain, and

insomnia. Her current medications are as follows: lisinopril 20 mg po daily, verapamil 180 mg po daily, metformin 500 mg po bid,
oxycodone controlled-release 10 mg po bid, oxycodone 5 mg q4h prn pain (using 2-3 doses per week), zolpidem 5 mg po ghs.

Which of Mrs. Smith’s current medications (other than

oxycodone) is most likely contributing to constipation?

a. Lisinopril
b. Verapamil
c. Metformin

d. Zolpidem

18 MARYLAND PHARMACIST | FALL 2016

The answer is B. Of the antihypertensives, calcium channel
blockers are most likely to cause constipation. Metformin is
more likely to cause diarrhea.

What first line treatment would you recommend at this
time for Mrs. Smith?
a. Senna

b. Senna plus docusate

Table 1. Prescribing Information for First Line Treatments2?

Usual Dosing of Action Precautions Effects

Senna Direct stimulation | Do not use if Intestinal colic,
17.2 mg po daily to 34.4 mg po |of peristalsis suspected GI diarrhea
bid obstruction;
Bisacodyl undiagnosed nausea
10-20 mg po daily or vomiting
Rectal suppository: 10 mg daily
Lactulose
10-20 grams (15-30 mL) po
daily
Polyethylene Glycol
17 grams (mix powder with 80z
fluid) po daily
Magnesium salts
Magnesium hydroxide: 400 to
800 mg po daily

Magnesium citrate: 195 to 300
mL po daily

Rectal irritation
with suppository

Osmotic; promote
secretion of fluid
into the bowel

Magnesium salts are
contraindicated in
patients with renal
impairment

GI upset (bloating
and gas especially);
electrolyte

imbalance

derivative of the mu-opioid receptor naloxone which and seen more frequently with the 25 mg dose of
has limited ability to penetrate the blood brain barrier.*° naloxegol. Pain scores and opioid doses were similar
Naloxegol was evaluated in two double-blind tnals between experimental and control groups. Alvimopan,
and a total of 1,352 patients with CNCP.* Subjects another PAMORA, is only approved for the prevention
treated with naloxegol 12.5 mg or 25 mg daily had of post-operative ileus for patients in the hospital. It is
higher response rates after 12 weeks of treatment than not approved for outpatient use due to the potential for
those administered placebo (44.4% vs 29.4%, P=0.001). cardiac toxicity with long-term use, and is therefore not
In this study, GI adverse effects were most common covered in depth in this article.“

c. Polyethylene glycol of her long-acting oxycodone to relieve the constipation

Hat actioce resulting in less control of her chronic pain.

A and C are both correct answers. Although there is little What course of action do you recommend for
evidence to point the way, the best options in this list in terms Mrs. Smith at this time?

of efficacy are senna, polyethylene glycol, and lactulose.
Adding docusate does not improve outcomes. In regard
to tolerability, senna or polyethylene glycol may be better b. Recommend lactulose
options; patients tend to complain of bloating, flatulence, as c. Refer to primary care physician
well as the taste of lactulose.

a. Recommend methylcellulose

d. Refer to emergency department
Over the course of three months, Mrs. Smith's bowel regimen

escalates to senna three tablets bid, polyethylene glycol po
daily, magnesium citrate 30 mL po ghs, and mineral oil enema
as needed. She comes in to your pharmacy and complains
that despite this increasingly burdensome regimen, she still
has infrequent bowel movements which require straining

to pass. She asks if there are any other OTC products she

can try. Upon questioning you find out that her last bowel
movement was 5 days ago, which she describes as “a shmear”.
She complains of fullness, decreased appetite, and nausea
and denies vomiting. Additionally, she has tried to skip doses

The answer is C. Mrs. Smith should be referred to her
primary care physician at this time. She has not had a bowel
movement in almost a week and is experiencing nausea. She
should be evaluated to ensure there is no bowel obstruction
or fecal impaction. She may need an enema, manual
disimpaction, or treatment with a drug like methylnaltrexone.
Methylcellulose, a bulk forming laxative, could increase

the risk for obstruction. She is already taking two osmotic
laxatives; lactulose would not likely add benefit to this
regimen.

MARYLANDPHARMACIST.ORG 19

Lubiprostone was approved in 2013 for OIC resulting
from chronic opioid use for CNCP, and had previously
been approved for the treatment of chronic idiopathic
constipation and constipation associated with tmitable
bowel syndrome (IBS).*° Lubiprostone activates chloride
channels in the intestine that increases fluid secretion
and motility.“ In a randomized, double-blind, placebo-
controlled study, subjects treated with 24 mcg twice
daily had higher response rates after 12 weeks than
those treated twice daily with placebo (27.1% vs 18.9%,
P=0.030).2° Because methadone inhibits activations of
the chloride channel, patients taking methadone were
not included in lubiprostone studies.* The efficacy of
lubiprostone was compared to senna for the treatment
of OIC in post-surgical patients. Both treatments
improved constipation symptoms and quality of life
with no significant between-group differences. “°

In the Pipeline

Several classes of drugs are currently being

evaluated in clinical trials to broaden the range of
treatments available for patients with opioid-induced
constipation.*” PAMORASs currently under investigation
include axelopran and naldemedine. Also under
investigation is prucalopride, a serotonin (5-HT,)
receptor agonist. Linaclotide is a guanylate cyclase-C
agonist which increases intestinal secretions. It is
currently approved for idiopathic constipation and IBS
and is being studied for use in OIC.

Role of the Community Pharmacist

Aside from educating patients about the benefits
and risks of traditional and newer treatments for
OIC, community pharmacists can be invaluable in
preventing and detecting the condition. Any patient

Table 2. Prescribing Information for Targeted Therapies”®

Drug Name/
Usual Dosing
Methylnaltrexone

Advanced illness: 8-12 mg
subQ every other day

CNCP: 12 mg subQ daily or
450 mg po daily

Peripherally-
acting mu opioid
antagonist

Naloxegol
25 mg po daily

Chloride channel
antagonist

Lubiprostone
24 mcg twice daily

20 MARYLAND PHARMACIST | FALL 2016

Mechanism Warnings/ Adverse
of Action Precautions Effects

Contraindicated in
known/ suspected GI
obstruction

Abdominal pain,
nausea, gas,
diarrhea,

Dose adjust in renal headache

dysfunction

Contraindicated in
known/ suspected GI
obstruction

Abdominal pain,
nausea, gas,
diarrhea,

Dose adjust in renal headache

dysfunction

Avoid use with
moderate CYP 3A4
inhibitors;
contraindicated with
strong CYP3A4
inhibitors
Contraindicated in
known/ suspected GI
obstruction

Abdominal pain,
nausea, gas,
diarrhea,

Reduce dose in SENSE

moderate to severe
hepatic dysfunction

May cause dyspnea
within 30-60 min of
dose; resolves within
hours

CE Questions

Which of the following best describes the primary
mechanism of action of bisacodyl?
a. Increased fecal mass resulting in peristalsis
b. Antagonism of mu opioid receptors in the GI tract
c. Direct stimulation of the large intestine resulting in
peristalsis
d. Increased retention of fluid in the bowel resulting
in softer stool

Which of the following is a red flag symptom
indicating a need for triage in a patient experiencing
OIC?

a. Bloating

b. Hard stools

c. Decreased appetite

d. Unexplained abdominal pain

Which of the following medications is most likely
to increase the risk of developing constipation in a
person also taking opioids for pain?

a. Sitagliptin

b. Amoxicillin

c. Amitriptyline

d. Metoclopramide

True or false: Docusate improves stool frequency,
consistency, and volume when added to senna.

True or false: Bulk forming laxatives may worsen OIC
and should not be used by patients taking opioids.

Which of the following OTC medications is available
as a rectal suppository?

a. Senna

b. Bisacodyl

c. Docusate

d. Lactulose

Which of the following medications must be avoided
in patients taking moderate or strong CYP3A4
inhibitors?

a. Methylnaltrexone

b. Lubiprostone

c. Naloxegol

d. Bisacodyl

Which of the following medications must be dose
adjusted in moderate to severe hepatic dysfunction?
a. Bisacodyl
b. Lubiprostone
c. Methyltnaltrexone
d. Naloxegol

Which of the following medications should NOT
be used when treating OIC in patients taking
methadone?

a. Methylnaltrexone

b. Lubiprostone

c. Naloxegol

d. Bisacodyl

10 Which of the following oral PAMORAs was recently
approved for the treatment of OIC?
a. Axelopran
b. Alvimopan
c. Naldemidine
d. Methyltnaltrexone

Answers on page 24

Save the Dates

O0@

Pharmacists Month Board of Trustees
Medication Errors CE Meeting
in cooperation with November 17
the U.S. Food
and Drug
Administration
October 27

December 15

MPhA Holiday Party

Board of Trustees MPhA 2017 Mid-Year Maryland Pharmacy
Meeting Meeting — DoubleTree Coalition Legislative

January 19, 2017 Hilton, Columbia, MD Day — Annapolis, MD
February 12, 2017 February 16, 2017

All activities held at MPhA Headquarters unless otherwise noted.

Visit www.marylandpharmacist.org to register online or for more information.

MARYLANDPHARMACIST.ORG 21

Table 3. Contributing factors to constipation??

Calcium channel blockers
e Anticholinergics (including antihista-
mines and some antidepressants)

e Antipsychotics
e SHT, antagonists
Oral iron

who receives a new prescription for opioids should
be counseled on the potential for OIC. Patients who
are taking long-acting opioids, including transdermal
patches such as fentanyl or buprenorphine, should
also be taking a first line medication (e.g., stimulant or
osmotic laxative) to prevent the development of OIC.
Although lifestyle modifications alone are unlikely

to successfully treat or prevent the development of
OIC, addressing contributing factors may be helpful.
Pharmacists can help identify other constipating
medications in the patient's regimen and may be able
to identify and address reversible functional factors
(Table 3).

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22 MARYLAND PHARMACIST | FALL 2016

Functional Factors

e Poor food/fluid intake

e Decreased mobility

e Depression

e Sedation

e Lack of privacy for toileting

e Need for assistance with toileting

Important counseling points include informing patients
that they should ideally be having a soft, easy-to-

pass bowel movement daily. Patients who go four
days or more without a bowel movement should

be referred to their primary care provider. Likewise,
patients who present with constipation and red-flag
signs or symptoms, such as abdominal pain, nausea,
or vomiting, should be triaged to their primary care
provider or urgent care. OIC is predictable and often
preventable, and pharmacists play an important role in
the assessment, education, and care of patients who
require opioids for pain management. @

Special thanks for editorial contributions provided by
Kathleen Pincus, PharmD, BCPS

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References 9 Camilleri, M. Opioid-Induced Health Analytics; 2016 |[accessed

1. Institute of Medicine of the National Constipation: Challenges and 14 July 2016]. Available from
Academies Report. Relieving Therapeutic Outcomes. Am J www.micromedexsolutions.com
Pain in America: A Blueprint for Gastroenterol. 2011;106:835-842 Subscription required to view
Transforming Prevention, Care, 10 Senna. In: DRUGDEX [database on 11 Brenner DM. Stimulant laxatives
Education, and Research, 2011. the internet]. Ann Arbor (MI): Truven for the treatment of chronic

The National Academies ————————————————————— ae eS fe
Press, Washington DC.
http://books.nap.edu/
openbook.php?record_
id=13172Spage=5. Accessed
2 Aug 2016.

2 AAPM facts and figures
on pain. The American

Academy of Pain Medicine

website. http://www. CS M M | ale M i iN |+
painmed.org/PatientCenter/
Facts_on_Pain.aspx.

Accessed 2 August 2016 Protect your

3 Dorn S, Lembo A, Cremonini patients.
F. Opioid-induced bowel

dysfunction: epidemiology, Protect your

pathophysiology, pha rmacy.
diagnosis, and initial

therapeutic approach. Am ERRORS CAN INJURE
J Gasteroenterol Suppl. PATIENTS AND PUT

2014; 2(1):31-37

4 Panchal SJ, Muller-
Schwefe P, Wurzelmann
JI. Opioid-induced bowel
dysfunction: prevalence,
pathophysiology and
burden. Int J Clin Pract.
2.007;61(7):1181-1187.

5 Thomas J. Opioid-induced
bowel dysfunction. J
Pain Symptom Manage.
2008 590)105-115.

6 Bell TJ, Panchal SJ,
Miaskowski C, et al. The
prevalence, severity, and
impact of opiocid-induced
bowel dysfunction: results
of a US and European
Patient Survey (PROBE 1).
Pain Med. 2009;10(1):35-42.

7 Gaertner J, Siemans W,
Camilleri M, Davies A,
Drossman DA, Webster
LR, Becker G. Definitions

YOUR PHARMACY IN
FINANCIAL JEOPARDY.

and outcome measures The PQC+ QA program can improve efficiency and
regarding opioid-— increase patient safety as well as help you meet accreditation,
induced constipation: a credentialing, PBM and state Quality Assurance requirements.
eystematic review. J Us * Training, Quality Assurance CE, and resources
Gastroeneterol. 2015;49:9- * Patient Safety Organization protection for your QA work
16. * Practical tools to collect and analyze patient safety data
8 Holzer P. Pharmacology of :
opioids and their effects on g
=) A b M S Learn more at www.medicationsafety.org or call us at (866) 365-7472.

gastrointestinal function
Am J Gastroenterol Suppl
2014;2:9-16.

Alliance for Patient Medication Safety The Alliance of Medication Safety (APMS) is a federally listed Patient Safety Organization (PSO).

MARYLANDPHARMACIST.ORG 23

constipation: is it time to change
the paradigm? Gastroenterology.
2012;142(2):402-404.

12 Twycross R, Sykes N, Mihalyo M,
Wilcock A. Stimulant laxatives and
opioid-induced constipation. J Pain
Symptom Manage. 2012;43(2):306-
Si:

13 Liu LW. Chronic constipation:
current treatment options. Can
J Gastroenterol. 2011;25(Suppl
B):S22-S28.

14 Tarumi Y, Wilson MP, Szafran O,
Spooner GR. Randomized, double-
blind, placebo-controlled trial of
oral docusate in the management
of constipation in hospice patients.
J Pain Symptom Manage. 2013.
45(1):2-13

15 Woolery M, Bisanz A, Lyons HF,
Gaido L, Yenulevich M, Fulton S, et
al. Putting evidence Into practice:
evidence-based interventions for
the prevention and management of
constipation in patients With cancer.
Clin J Nurs Oncol. 2008;12(2;):317-
S27

16 Kumar L, Barker C, Emmanuel
A. Opioid-induced constipation:
pathophysiology, clinical
consequences, and management.
Gastroenterol Res Pract. 2014;
Article ID 141737.

17 Slatkin N, Thomas J, Lipman
AG, Wilson G, Boatwright ML,
Wellman C, et al. Methylnaltrexone
for treatment of opioid-induced
constipation in advanced illness

patients. J Support Oncol.
2009;7(1):39-46.

18 Michna E, Blonsky ER, Schulman S,
Tzanis E, Manley A, Zhang H, et al.
Subcutaneous methylnaltrexone
for treatment of opioid-induced
constipation in patients with
chronic, non-cancer pain: a

randomized controlled study. J Pain.

2011;12(5):554-562.

19 Jones R, Prommer E, Backstedt D.
Naloxegol: a novel therapy in the
management of opioid-induced
constsipation. Am J Hospice Palliat
Med. 2015 [epub ahead of print];
doi: 10.1177/1049909115593937

20 Naloxegol. In: DRUGDEX [database
on the internet]. Ann Arbor (MI):
Truven Health Analytics; 2016
[accessed 14 July 2016]. Available
from: www.micromedexsolutions.
com. Subscription required to view.

21 Chey WD, Lebster L, Sostek M, et
al. Naloxegol for opioid-induced
constipation in patients with
noncancer pain. N Engl J Med.
2014; 570:258/-2596,

22 Alvimopan. In: DRUGDEX [database
on the internet]. Ann Arbor (MI):
Truven Health Analytics; 2016
[accessed 14 July 2016]. Available
from: www.micromedexsolutions.
com. Subscription required to view.

23 Amitiza [package insert]. Bethesda,
MD: Sucampo Pharmaceuticals, Inc;
2013.

24 Lubiprostone. In: DRUGDEX
[database on the internet).

Ann Arbor (MI): Truven Health
Analytics; 2016 [accessed 14
July 2016]. Available from: www.
micromedexsolutions.com.
Subscription required to view.

25 Jamal MM, Adams AB, Jansen JP,
Webster LR. A randomized, placebo-
controlled trial of lubiprostone
for opioid-induced constipation
in chronic noncancer pain. Am J
Gastroenterol. 2015;110(5):725-732.

26 Marciniak CM, Toledo S, Lee J,
Jesselson M, Bateman J, Grover
G, et al. Lubiprostone vs senna in
postoperative orthopedic surgery
patients with opioid-induced
constipation: a double-blind,
active-comparator trial. World J
Gastroenterol. 2014;20(43):16323-
16455.

27 ClinicalTrials.gov: A service of the
US. National Institutes of Health
[internet]. Accessed 2016 Aug 8.
Available from https://clinicaltrials.
gov/ct2/nome.

28 DRUGDEX [database on the
internet]. Ann Arbor (MI): Truven
Health Analytics; 2016 [accessed
14 July 2016]. Available from:
www.micromedexsolutions.com.
Subscription required to view.

29 Larkin PJ, Sykes NP, Centeno C,
et al; European Consensus Group
on Constipation in Palliative Care.
The management of constipation
in palliative care: clinical practice
recommendations. Palliat Med.
2008; 22(7):796-807.

CONTINUING EDUCATION QUIZ

PharmCon is accredited by
the Accreditation Council
for Pharmacy Education as
a provider of continuing
pharmacy education. A
continuing education credit
will be awarded within six to

eet

eight weeks.
Program Release Date: 09/27/16
Program Expiration Date: 09/27/19

This program provides for 1.0 contact
hour (0.1) of continuing education
credit. Universal Activity Number (UAN)
0798-9999-16-132-H01-P

CE Questions Answers from page 21

The authors have no financial disclosures
to report.

This program is Knowledge Based —
acquiring factual knowledge that is based
on evidence as accepted in the literature
by the health care professionals.

Directions for taking this issue's quiz:

This issue's quiz on Treating Opioid-
Induced Constipation: A Community
Pharmacy Perspective can be found
online

at www.PharmCon.com.

(1) Click on “Obtain Your Statement of
CE Credits for the first time.

1) c, 2) d, 3) c, 4) False, 5) True, 6) b, 7) c, 8) b, 9) b, 10) a

24 MARYLAND PHARMACIST | FALL 2016

(2) Scroll down to Homestudy/
OnDemand CE Credits and select the
Quiz you want to take.

Log in using your username (your
email address) and Password
MPHA123 (case sensitive). Please
change your password after logging
in to protect your privacy.

(4) Click the Test link to take the quiz.

Note: If this is not the first time you are
signing in, just scroll down to Homestudy/
OnDemand CE Credits and select the quiz
you want to take.

Third Quarter 2016:
Pharmacy Time Capsule

By: Dennis B. Worthen, PhD, Cincinnati, OH

One of the early effects means of separating
1) YX of the DESI study was _ plasma from whole
the development of the blood and storing it for
1966 Abbreviated New Drug future use.
FDA contracted with Application (ANDA).
the National Research USE
Council to undertake bs
Chicago College of the Drug Efficacy Study Bax fer 1916
Pharmacy—Midwestern Implementation (DESI) 4941 The US

University established Program to determine
at Downers Grove, IL the efficacy of products Baxter introduces the Pharmacopoeia drops
Plasma-Vac container, whiskey and brandy

: 1962.
TRETIEIES Fas Slate h Ake ener providing the first from its list of drugs.

One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit
society dedicated to assuring that the contributions of your profession endure as a part of America’s history.
Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or
more historical publications to your door each year. To learn more, check out: www.aihp.org

Charles Armstrong Kenny Kwack Kimberly Santa
Daniel Boring Fatemeh Mohammadi Cruz

Barbara Caci Francee Nichalson Demita Simon

W = LCO M E Emily Diseroad Mary Ogunwuyi Paul Solinsky
NEW MEMBERS Rivkha Garcia Mamta Parikh Deborah Spencer

Kyle Gundlach Joseph Parson Cindy Warriner
Sunyup Hwang Xuan Pham McKay Whiting
Amar Kalidindi Twillow Rhodes

Henry Kamdem Mohamed Sackor

THANK YOU TO OUR 2016 CORPORATE SPONSORS

Boehringer Ingelheim Care Pharmacies
McKesson Corporation PharmCon/FreeCE.com
Pharmacists Mutual Companies Rite Aid
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MARYLANDPHARMACIST.ORG 25

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You Care For Your Communi

ing

Help

Executive Director’s Message

What's Your Story?

During my time at
MPhA, I've had the
opportunity to tell the
pharmacists’ “story”

to members of the
public, healthcare
stakeholders, elected
and appointed officials,
as well as friends and
family. Each time your
story is told, there is

a new understanding
of the education and expertise you have; the role
you play in the healthcare system and in your
community; and the opportunities for Maryland
residents to receive quality information and patient
care from you.

I've also heard your MPhA stories. Many of you
joined MPhA through the encouragement of a
colleague or friend— you tagged along to one

of our public board meetings, felt welcomed,

and saw that we were living our mission and
values to advance and protect the profession.

I've also heard about the friendships that have
been forged through volunteering and committee
activity; connections built by MPhA recognizing
your professional achievements and academic
scholarship; and families creating generations

of Maryland pharmacists, who have served the
organization in both volunteer and leadership
Capacities. You've also shared stories about the
Annual Conventions, the museum, expansion of
pharmacy and pharmacy technician education,
passage of major legislation, our beloved crab feast,
and so many other events and milestones along the
way that have created our story.

MPhA! What a legacy and what a place to be! We
have more memories to make and more work

to do. As we embark on 2017, look to MPhA to
continue to share your story, but I also encourage
you to do the same. We are stronger when we
have more voices in the game. Encourage MPhA
membership, bring a friend or colleague to the next
MPhA meeting or event, take a young pharmacist
or pharmacy technician under your wing, or be
prepared to call or meet with a Delegate during

Legislative Session. Our Networks for New
Practitioners, Federal Pharmacists, and Technicians
are creating pathways of activity and engagement
where we truly bring together the pharmacy
community. We need you AND your colleagues.

We have more memories to make and
more work to do. As we embark on
2017, look to MPhA to continue to share
your story, but | also encourage you to
do the same. We are stronger when we
have more voices in the game.

Here's a bit of my story. Not long after joining
MPhA, I learned that my great-grandfather had
been a pharmacist (I only knew that he was a
physician). He arrived on Ellis Island from Jamaica
in 1916. The manifest listed his occupation as a
druggist. He encountered many trials but eventually
opened a pharmacy in a community called Sugar
Hill in Harlem, NY. Due to his compassion and
care, he was credited with helping many families
survive the Great Depression. He later went to
medical school, at the age of 47, and served at

the Sydenham Hospital into the mid-1970s. His
pharmacy remained open until his passing.

This story reminded me of not only of the

role pharmacists have and continue to play in
communities, but also the ability of this type of
career to change the trajectory of a family for
generations. So during this Pharmacists Month, I
salute all of you and my great-grandfather, Josiah
"Doc’ Bellamy. @

Best regards,

’

Executive Director

PS. Share your Story at www.facebook.com/
MarylandPharmacistsAssociation/

MARYLANDPHARMACIST.ORG 27

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the University of Maryland e Assist with medication management and storage
School of Pharmacy offers ¢ Conduct medication profile reviews
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Assist with patients’ medication histories

¢ Complete medication checking

¢ Monitor for medication errors

¢ Facilitate improvement of the medication process

and interactive learning
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Career advancement opportunities for technicians
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Medication reconciliation technician
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